| Public Health Service Food and Drug Administration |
| Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human Services
November 23, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-06
Fawn R. Sharp
President and Chief Executive Officer
Quinault Indian Nation.
P.O. Box 217
Taholah, Washington 98587
WARNING LETTER
Dear Ms. Sharp:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing and low-acid canned food manufacturing facility, Quinault Tribal Enterprise (QTE), located at 100 West Quinault Street, Taholah, Washington, on April 28, 2011, through May 12, 2011. The inspection found that your firm manufactures the following canned seafood in hermetically sealed cans: smoked salmon, smoked sturgeon, smoked tuna, albacore tuna, and minced razor clams. During the inspection, our investigators observed serious deviations from the Low-Acid Canned Food regulations, Title 21, Code of Federal Regulations, Parts 108 and 113 (21 CFR 108 and 113) and the Good Manufacturing Practices regulations, 21 CFR 110.
As a manufacturer of low-acid canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. In addition, as a processor of seafood products, you are also required to comply with 21 CFR 123, Fish and Fishery Products. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 United States Code (U.S.C.) § 344]. A temporary emergency permit may be required for low-acid canned foods whenever a processor has failed to fulfill the mandatory requirements of 21 CFR 108 and 113.
The inspection revealed that your low-acid canned seafood products are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and the low-acid food regulations through links in FDA's homepage at http://www.fda.gov.
We received a response letter from Mr. Everett W. Masten, Assistant General Manager, dated May 19, 2011, regarding our investigator's observations noted on the Form FDA 483, Inspectional Observations, and your firm's voluntary corrections. We acknowledge that QTE voluntarily recalled all canned seafood products manufactured at your facility and issued a press release regarding the recall on April 29, 2011. We address each response below, in relation to each of the noted violations.
The significant violations include, but are not limited to, the following:
1. Failure to report to the FDA any instances of process deviation the nature of which indicates potential health significance where any lot has in whole or in part entered distribution as required by 21 CFR 108.35(d). Specifically, you failed to notify the FDA after being informed in November 2010, by your processing authority, (b)(4) of severe looseness of your double can seams. You proceeded to conduct a limited and ineffective recall. We acknowledge that your firm voluntarily recalled all canned products processed at your facility and issued a national press release on April 29, 2011. Inadequate or improper manufacturing, processing, or packing of thermally processed low-acid foods in hermetically sealed containers could foster the growth of microorganisms such as Clostridium botulinum that could potentially cause illness or even fatal food poisoning.
We note in your written response that you acknowledged the oversight by QTE for not reporting the can seam defects to the FDA. However, we conclude that your written response is inadequate because it lacks any detailed corrective actions to prevent this violation from recurring in the future.
2. Failure to prepare and maintain current procedures for products under your control and which you will ask your distributors to follow, including plans for effecting recalls of any products that may be injurious to health; for identifying, collecting, warehousing, and controlling the product; for determining the effectiveness of such recall; for notifying the FDA of any such recall; and for implementing such recall program as require by 21 CFR 108.35(f). Specifically, a recall procedure on file was requested and could not be provided to our investigator during the inspection.
We acknowledge that a copy of the recall procedure was included as part of your written response, however, we were not able to evaluate the procedure because it was incomplete in that pages were missing and portions were unreadable due to its poor photocopy quality. Furthermore, there is no evidence that you followed your recall procedure.
3. Your firm failed to perform and record teardown examinations at intervals of sufficient frequency on containers from your seaming station to ensure maintenance of seam integrity as required by 21 CFR 113.60(a)(1). Specifically, there are no double seam examination records for 26 days out of (b)(4) days of production of various canned seafood products between January 2, 2008, and April 1, 2011. In addition, all teardown examination records for your double can seams from February 2008, through December 2010, appear to have identical seam measurements. Also, there is no documentation of corrective actions taken when you were notified in November 2010, by your processing authority of the can seam defects. During our inspection, your firm did not have can seam tear down equipment on site to perform teardown examinations, including a countersink gauge, micrometer, nippers, or a can opener.
During the inspection, we collected 25 samples of various canned seafood products with manufacturing dates ranging from August 14, 2009, to December 22, 2010. The samples were analyzed by FDA's Pacific Regional Laboratory Northwest (PRLNW), Pacific Regional Laboratory Southwest (PRLSW), and Arkansas Regional Laboratory (ARL). Laboratory analysis confirmed that all 25 samples were inadequately hermetically sealed with can seam measurements (thickness, cover hook, body hook, and tightness) that indicated the absence of a second seam operation. On May 3, 2011, sample #689507, consisted of 72 cans of smoked salmon manufactured on December 10, 2010, was collected and analyzed by FDA's ARL. Laboratory analysis confirmed an inadequate hermetic seal and the presence of viable Gram-positive and Gram-negative aerobic and anaerobic microorganisms. On May 2, 2011, sample #689499, consisted of 72 cans of albacore tuna manufactured on December 20, 2010, was collected and analyzed by FDA's PRLSW. Laboratory analysis confirmed an inadequate hermetic seal and the presence of viable microorganisms including Bacillus licheniformis, Rhizobium radiobacter, Pseudomonas aeruginosa, and Serratia marcescens. On May 2, 2011, sample #689500, consisted of 72 cans of albacore tuna manufactured on December 22, 2010, was collected and analyzed by FDA's PRLSW. Laboratory analysis confirmed an inadequate hermetic seal and the presence of viable Staphylococcus sciuri.
We reviewed your written response and it is inadequate because it lacks specific details on corrective actions you have taken or will be taking to prevent this violation from recurring in the future. Such specifics may include procedures, training, and documentation for can teardown examination and for corrective actions taken when notified of container closure irregularities. Note that an invoice for equipment repair is inadequate documentation of corrective actions taken to correct can seam defects.
4. Your firm failed to mark each hermetically sealed container of low-acid processed food with an identifying code that shall be permanently visible to the naked eye as required by 21 CFR 113.60(c). Specifically, your embossed manufacturing codes on your low-acid canned food products were not consistently legible to the naked eye.
We reviewed your written response and it is inadequate because it lacks specific details and timeframes on corrective actions you have taken or will take to correct this violation.
5. Failure to measure and record at intervals of sufficient frequency the maximum fill-in weight as specified in your scheduled process to ensure that the weight does not exceed the maximum for the given container size specified in the scheduled process as required by 21 CFR 113.40(a)(13)(i). Specifically, there is no record of the meat fill-in weight for the minced razor clams processed on April 28, 2010, and May 18, 2010, as specified in your scheduled process.
We reviewed your written response and it is inadequate. While your written response promised to obtain the proper meat fill for your minced razor clams, there were no corrective actions in terms of specific procedures, training, and documentation that ensure the fill-in weight for the minced razor clams does not exceed the maximum weight specified in your scheduled process.
6. Failure to record process deviations and corrective actions taken involving a failure to satisfy the minimum requirements of the scheduled process as required by 21 CFR 113.89. Specifically, there are no records of process deviations and corrective actions taken when the recorded initial temperature (I.T.) was below the minimum I.T. specified in your scheduled process for 32 lots of low-acid canned food products manufactured between January 2, 2008, and March 31, 2011. The Retort Operator stated to our investigator that he was not aware that the I.T. could not be lower than the minimum I.T. specified in your scheduled process.
We reviewed your written response and it is inadequate because there were no specific corrective actions such as procedures, training, and documentation to ensure the I.T. is not below the minimum I.T. specified in your scheduled process before the start of the thermal processing of the canned products.
7. Failure to arrange bleeders so that the operator can observe that they are functioning properly as required by 21 CFR 113.40(a)(8). Specifically, the operator could not observe the bleeders to ensure they are functioning properly throughout the thermal processing period.
We reviewed your written response and it is inadequate because it lacks specific details and timeframes on corrective actions you have taken or will take to ensure the Retort Operator will be able to observe the bleeders during the thermal processing period. This violation was observed and cited in previous FDA inspections.
8. Failure to adjust the temperature-recording device such that it is in no event higher than the known accurate mercury-in-glass thermometer during the process time and to prevent the unauthorized changes to the temperature-recording device as required by 21 CFR 113.40(a)(2). Specifically, your temperature-recording device was recording temperatures greater than the temperatures recorded from your mercury-in-glass thermometer for 47 days out of (b)(4) production days as indicated in Daily Process Record Form for Still Retorts. Furthermore, there is no lock or notice posted at or near the temperature-recording device to prevent any unauthorized changes to the temperature-recording device.
We reviewed your written response and it is inadequate because it lacks specific details and timeframes on corrective actions such as procedures, training, and documentation to correct and prevent this violation from recurring in the future. This violation was observed and cited in previous FDA inspections.
9. Failure to sign or initial and date each processing and production record by the retort or processing system operator or designated person, and by a representative of the firm management for completeness to ensure that the low-acid food product received the scheduled process including the recording thermometer charts as required by 21 CFR 113.100(b). Specifically, the following violations were observed by our investigators:
a. The Daily Process Record Form for Still Retorts were not signed or initialed and dated by the retort operator or designated person for 4 days out of (b)(4) production days between February 29, 2008, and December 10, 2010.
b. The Daily Process Record Form for Still Retorts were not signed or initialed and dated by the reviewer for 21 days out of (b)(4) production days between February 29, 2008, and December 22, 2010.
c. The (b)(4) brand temperature recording charts were not signed or initialed and dated by the reviewer for 23 days out of the (b)(4) production days between February 29, 2008, and December 22, 2010.
We reviewed your written response and it is inadequate because it lacks specific details on corrective actions you have taken or will take to prevent this violation from recurring in the future. This violation was observed and cited in previous FDA inspections.
10. Your firm failed to take effective measures to exclude pests from the processing area and to protect against the contamination of food on the premises by pests as required by 21 CFR Part 110.35(c). Specifically, in the following instances pests were observed in your facility during our inspection:
a. On May 3, 2011, and May 4, 2011, rodent excreta pellets (REPs) were observed throughout the facility, as evidenced by:
i. Four REPs were observed under the pallet jacks located adjacent to the walk in cooler and fish processing room on the 151 floor.
ii. Two REPs were observed about 20 feet south of a pallet of flattened finished product boxes on the 1st floor.
iii. Three REPs were observed along the south wall behind the refrigerator/cooler adjacent to the roll up door on the 1st floor.
iv. Five feline droppings and 185 REPs were observed on the floor and on a wall beam in the southwest comer of the packaging material storage area on the 2nd floor.
v. Twenty REPs were observed along the south wall approximately 10 to 20 feet from the southwest comer in the packaging material storage area on the 2nd floor.
vi. Four REPs were observed beneath the first pallet of flattened packaging material to the right of the stairs in the packaging material storage area on the 2nd floor.
vii. Twenty-nine REPs were observed on shelves across the tire storage area along the walkway between the stairs leading to the packaging room and the storage area above the clam processing room on the 2nd floor.
vii. Along the west wall in the storage area above the clam processing room and 10 feet from a pallet of new (b)(4) brand cans on the 2nd floor, our investigator observed 116 REPs.
ix. Twenty-six REPs were observed embedded in the insulation hanging from the ceiling in the storage area above the clam hand packaging room on the 2nd floor.
b. On May 3, 2011, bird feathers and bird droppings were observed throughout the facility, as evidenced by:
i. Five bird feathers were observed on the floor near the south roll up door on the 1st floor.
ii. Two bird feathers were observed inside the fish processing room on the 1st floor.
iii. Two bird feathers were observed in the packaging storage area on the 2nd floor.
iv. Four bird droppings were observed in the packaging storage area on the 2nd floor.
c. On May 3, 2011, sample #645561, consisted of two feline hairs and a dermestid beetle larval head attached to a feline jaw bone were collected from the storage area along the south wall approximately 30 feet from the southwest corner of your building.
d. On May 3, 2011, sample #645560, was collected from various locations on the 2nd floor storage area and was analyzed by FDA's PRLNW. Laboratory analysis confirmed the dead insects, specifically:
i. Five hatched blow fly puparia (Calliphora) and eight larval cast skins of warehouse beetle (Trogoderma) were collected from the southwest corner adjacent to finished product packaging boxes.
ii. Three hatched blow fly puparia (Calliphora), two dead sowbugs (Oniscus), and 11 canine/feline hairs were collected in the storage area above the retort and clam processing rooms.
We reviewed your written response and noted the corrective actions you intend to take to correct the noted violations. However, your response of cleaning and disposing of all REPs lacked specific corrective actions you have taken or will take to prevent these sanitation deficiencies and training of employees about sanitation practices, regulations, and policies. We will verify the corrections at the next inspection of your facility.
11. Your firm failed to provide adequate screening or other protection against pests required by 21 CFR Part 110.20(b)(7). Specifically, on May 2, 2011, through May 4, 2011, openings that allow pest access to food, food packaging, and food contact surfaces were observed throughout the facility, as evidenced by:
a. An approximately 3 inch opening to the outside was observed at the support beam wall/ceiling juncture in the storage area above the clam processing room. Water was observed leaking down from the ceiling in the clam hand packaging room.
b. An approximately 4 inch gap was observed between the window sill and a piece of plywood in the retort room. This plywood was used as a window covering.
c. An approximately 8 inch gap was observed in the south wall of the retort room approximately 12 feet up the wall leading to the tire storage walkway where apparent pest activity was found.
d. An approximately 8 inch by 3 inch gap to the outside was observed in the wall/ceiling juncture in the northeast comer of the retort room.
e. Northwest and northeast roll up doors leading to the fish processing room remained open during business hours. The northeast roll up door was observed to have missing sections in the strip curtain.
f. An approximately 1-2 inch gap to the outside was observed between the main south roll up door and the floor.
g. An approximately 3 inch gap to the outside was observed around a pipe adjacent to the southeast roll up door.
h. An approximately 3 inch gap to the outside was observed along the north wall adjacent to the northwest roll up door.
i. An open door to the roof remained open and unscreened where approximately 38 birds were observed resting on the roof.
We reviewed your written response and noted the corrective actions you intend to take to close openings and holes around your firm. However, your response lacked specific corrective actions you have taken or will take to ensure the openings and holes are properly closed to the outside environment. We will verify the corrections at the next inspection of your facility.
12. Your firm failed to keep the grounds located around your facility in a condition that will protect against the contamination of food by removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant, buildings, or structures that may constitute an attractant, breeding place, or harborage for pests as required by 21 CFR Part 110.20(a). Our investigator observed the following areas within the immediate vicinity of the building that may provide harborage for pests:
a. On May 2, 2011, through May 4, 2011, the storage area directly above the clam processing room on the 2nd floor was observed to be cluttered with unused equipment, an aquarium, office equipments, a dishwasher, plastic sheeting, a cement mixer, packing material, and other rubbish.
b. On May 3, 2011, pallets were observed to be stacked approximately 12 feet high against the east exterior wall of the building.
c. On May 3, 2011, pallets were observed to be stacked against the exterior wall of the southwest corner of the building.
d. On May 3, 2011, two vehicle windows and pallets were observed to be stacked against the west exterior wall of the building.
e. On May 3, 2011, overgrown vegetation and various unused bins and coolers were observed around the property.
We reviewed your written response and noted the corrective actions you intend to take to correct the noted violations. However, your response indicating that you will move all pallets away from the building, cut down all vegetation, and dispose all garbage lacked specific timeframes, procedures for completing the corrective actions to prevent these sanitation deficiencies from recurring, and training of employees about sanitation practices, regulation, and policies. We will verify the corrections at the next inspection of your facility.
13. Your firm failed to store sanitizing agents in a manner that protects against contamination of food, food-contact surfaces, or food packaging materials as required by 21 CFR Part 110.35(b)(2). On May 4, 2011, pallets of brown sugar were observed to be stored directly adjacent to containers of liquid bleach staged in a storage area between the clam hand packaging room and the clam processing room.
We reviewed your written response and noted the corrective actions you intend to take to correct the noted violations, including moving the bleach away from this area into a segregated area. However, your response lacked specific timeframes and procedures for completing the corrective action. We will verify the corrections at the next inspection of your facility.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
The nature of the violations are serious and as such, it is recommended that you seek assistance from your processing authority or hire a consultant with knowledge and experience in the manufacturing and processing of low-acid canned foods to help you bring QTE into compliance with all applicable federal laws and regulations.
You should respond in writing within fifteen ( 15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. You should also include in your response any documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your response to the U.S. Food and Drug Administration, Seattle District, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Peter C. Chow, Compliance Officer. If you have any questions regarding this letter, please contact Mr. Chow at (425) 483-4766.
Sincerely,
/S/
Charles M. Breen
District Director
No comments:
Post a Comment