| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT |
Department of Health and Human Services
WARNING LETTER
11-PHI-04
February 2, 2011
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
David N. Geise, President and CEO
Furman Foods, Inc.
770 Cannery Road
Northumberland, PA 17857-8615
Dear Mr. Geise:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified and low-acid canned food manufacturing facility, located at 770 Cannery Road, Northumberland, PA, from August 30, 2010 through September 10,2010. The inspection determined that your facility produced acidified and low-acid canned food products and revealed that you have significant violations of the Acidified Foods, Low-Acid Canned Foods, and Current Good Manufacturing Practice regulations, Title 21, Code of Federal Regulations, Parts 114, 113, and 110, respectively (21 CFR Parts 114, 113, and 110). Further, our investigators collected, and FDA analyzed a sample (6/6.25 lb pouches) of Rally's Chili with Beans, Lot # (b)(4). The laboratory results for this sample revealed a hard swell, viable unspeciated mold, seam defect, air bubbles and food product trapped within seam walls, and a pH of (b)(4) for sub #1. The pH for sub #2 and sub #3 were (b)(4) and (b)(4) respectively.
As a manufacturer of acidified and 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 acidified and low-acid canned food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), Part 114, Acidified Foods (21 CFR Part 114) and Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR Part 113). The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control (21 U.S.C. § 344). A temporary emergency permit may be required for low-acid canned foods and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35 and 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114 and 21 CFR Part 113. In addition, based upon certain criteria in 21 CFR 114 and 21 CFR 113, acidified and low-acid foods may be adulterated
within the meaning of section 402(a)(3) of the Act (21 U.S.C. § 342(a)(3)) in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4) (21 U.S.C. § 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health.
We have received your September 23, 2010, written response to the FDA Form 483, Inspectional Observations issued to your firm on September 10, 2010. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after each violation that is noted below.
The significant violations of 21 CFR parts 114 and 113 are as follows:
1. Your firm failed to establish a scheduled process for your acidified food by using a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods as required by 21 CFR 114.83. Specifically, your firm does not have a scheduled process established by an acidified foods expert for Rally's Chili with Beans, Lot (b)(4).
Your September 23,2010 response letter states that the Rally's Chili with Beans product is filed under SID (b)(4) (Chili, Beans and Tomatoes). This scheduled process refers to a May 11, 1998 (b)(4) process source letter that fails to identify the actual recommended process, including any critical factors, for this product. You will need to obtain the appropriate processing information from your process authority and revise your scheduled process on file with FDA as appropriate to include any critical factors that are identified. In addition, there was no Least Sterilization Value (LSV) submitted for this product, and therefore, the filed process does not explain how the cold spots (four corners of the pouch) receive the identified thermal treatment of (b)(4) during the hot fill and hold process.
2. You must test and examine containers often enough to ensure that containers suitably protect the food from leakage and contamination as required by 21 CFR 114.80(a)(4). Specifically, the investigators examined cartons of Rally's Chili with Beans and observed one pouch with a hard swell from Lot (b)(4). Our review of processing records for Lot (b)(4) indicated that there were no seam tests conducted, and therefore, the condition of this pouch indicates that your firm is not conducting container integrity testing at sufficient frequency to ensure the containers are protected from leakage and contamination.
FDA acknowledges that your firm's September 23,2010 response stated that you had identified issues with the filler's ability to consistently form good seals and that you continue to work with the equipment manufacturer to resolve the pouch seal issues. You also stated that you plan to increase the frequency of the pouch inspections from the current (b)(4) to every (b)(4). We do not consider your response acceptable in that your firm must identify which pouch inspections you plan to increase and determine and correct the point of malfunction in the pouch sealing equipment. This remains a significant concern and must be completely resolved to ensure that this problem does not reoccur.
3. You must perform appropriate detailed inspections and tests at intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable hermetic seal production on the product pouches as required by 21 CFR 113.60(a)(3). These examinations and tests must be carried out by qualified personnel at intervals of sufficient frequency to ensure proper closing machine performance. Specifically, the investigators conducted field examinations of Furmano's Dark Red Kidney Beans, Lot (b)(4) and Furmano's Pinto Beans, Lot (b)(4), which were located in your warehouse. The field exam of the Dark Red Kidney Beans revealed that of (b)(4) pouches, (b)(4) pouches had hard swells, (b)(4) pouches had splits at the seams (b)(4) were leakers, and over (b)(4) had rough seals. The field examination of the Pinto Beans revealed that (b)(4) cases each contained a pouch which had puncture-like wounds.
We acknowledge that these lots of product were voluntarily destroyed on September 20, 2010 based on the pouch examination findings and the resulting pest contamination. Further, your firm's September 23, 2010 response identifies the need to begin (b)(4) inspections of the entire warehouse in order to identify and remove containers that have failed and it identifies the need to increase destructive testing of pouch seals from the current (b)(4), to every (b)(4). However, the response does not address what type(s) of destructive test will be conducted and again. Further, it is important that you identify and correct the point of malfunction in the pouch sealing equipment. As stated previously, this remains a significant concern and must be completely resolved to ensure that this problem does not reoccur.
In addition, FDA investigators documented numerous significant violations of the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR 110). These violations cause food products manufactured in your firm to be 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 become contaminated with filth or may have been rendered injurious to health.
The significant violations of 21 CFR 110 are as follows:
4. Your firm failed to comply with 21 CFR 110.80(b)(5), which states that work-in-process shall be handled in a manner that protects against contamination. Specifically, on August 31, 2010 and September 8, 2010, your workers used power wash hoses to clean the floors and conveyor belts below and adjacent to the tomato lines. The force of the spray caused the water to aerosolize and come into contact with the peeled tomatoes on the conveyor above the cleaning area.
FDA acknowledges that your firm's September 23, 2010 response states that the employees were counseled at the time of the observation, that it was discussed with manufacturing employees on September 13, 2010, and that you will include "cross contamination" as part of your annual CGMP training. However, we do not consider your response adequate because you did not provide sufficient information for FDA to evaluate as to the specifics of what employees were told or will be told about preventing contamination during washing.
5. Your firm failed to comply with 21 CFR 110.37(b)(4), which states that plumbing shall be of adequate size and design and adequately installed and maintained to provide adequate floor drainage in all areas where normal operations release or discharge liquid waste on the floor. Specifically, on August 31,2010, the waste water discharge from your retort system had overflowed the discharge pit while your firm was in production.
FDA acknowledges that your firm's September 23, 2010 response states that the retort water discharge area was discussed with the maintenance team and that a corrective action plan has been developed to address this issue. However, we do not consider your response adequate because you did not provide the specifics of your corrective action plan for FDA to evaluate.
6. Your firm failed to comply with 21 CFR 110.35(c), which states that no pests shall be allowed in any area of a food plant and that effective measures shall be taken to protect against the contamination of food on the premises by pests. Your lack of effective pest control was observed during the inspection, as evidenced by the following:
a. On September 1, 2010, Furmano's Dark Red Kidney Beans, Lot (b)(4) was examined. There were (b)(4) pallets in the lot:
ii Pallet #1 consisted of (b)(4) cartons. The pallet contained flies under the plastic wrap. The case on the bottom layer on the SW corner had at least (b)(4) insects in it including (b)(4) live maggots crawling in it. Maggots, crawling insects, and flies were observed on the cases above it and to the sides of this case.
ii. Pallet #2 consisted of (b)(4) layers with (b)(4) cases to a layer. In the (b)(4) row from the top, the first case in the SE corner had two maggots, over (b)(4) insect casings, and (b)(4) fly in the case
iii. Pallet #3 is the same configuration as pallet #2. On the second row, in the first case, the last pouch on the right side of the case had exploded. Maggots were crawling around the opening at the side and top seams. (b)(4) maggots and (b)(4) flies were seen actively moving around. The pouch directly above it had (b)(4) live maggots on it. The remainder of the pouches in the case had insect casings and maggots on them. In addition, a beetle-like insect, maggots and insect casings were observed in the case itself. On the fourth layer, the first case in the NE corner had insect casings and a fly.
iv. Pallet #7 was the same configuration as pallet #2. On the first layer, the second case had one pouch, located on the right side, which had split at the seams and was swollen. The pouch had maggots on it.
b. On September 2, 2010, in the britestack section of the warehouse, a pallet of (b)(4) Dark Kidney Beans, Lot (b)(4), #10 cans was observed to have a swollen can that was covered with over (b)(4) maggots and flies.
c. On September 2, 2010, two pallets of Furmano's Pinto Beans, Lot (b)(4), were observed to have over twenty small flies on each pallet.
d. On September 1, 2010 and September 2,2010, one case of Rally's Chili with Beans, Lot (b)(4), was observed to have two flies on it.
We acknowledge that these products were voluntarily destroyed on September 20, 2010. Further, your firm's September 23, 2010 response identifies the need to begin weekly inspections of the entire warehouse in order to identify and remove containers that have any insect activity and to bring this to the immediate attention of Furman's Pest Professional for the appropriate actions. Your response appears to be adequate to address the violation of 21 CFR 110.35(c). We will verify the adequacy of your response during our next inspection.
7. Your firm failed to comply with 21 CFR 110.20(b)(5), which states that you must provide adequate lighting in all areas where food is examined, processed, or stored. Inspectors observed that the lighting in your warehouse areas was inadequate to conduct visual examinations of britestacks and finished product.
FDA acknowledges that your firm's September 23,2010 response states that your firm will take our concerns regarding inadequate lighting under advisement. We do not consider your response to be adequate because you did not provide the specifics of your corrective action plan for FDA to evaluate.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Acidified Foods regulations (21 CFR 114), the Low-Acid Canned Foods regulations (21 CFR 113), and the Current Good Manufacturing Practice regulations (21 CFR Part 110).
You should take prompt action to correct the violations described in this letter and to establish and implement procedures which will prevent them from occurring in the future. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
In addition to the above violations, we also have the following comment:
We reviewed the parameters for the "filed" process for Rally's Chili with Beans (SID (b)(4) and have concerns regarding the critical value for maximum equilibrium pH of (b)(4). While this value is the maximum pH permissible under the regulation 21 CFR Part 114, it causes concern since variations in pH measurement can clearly push the value above (b)(4). In addition, the "Hot Fill and Hold" process option selected provides minimal lethality with respect to non-pathogenic organisms that can spoil the product and raise the pH. At pH (b)(4), there are numerous acid tolerant spore forming organisms that grow and shift the pH upwards thus allowing C. botulinum to germinate and grow which will present a serious public health threat. A high pH value fails to provide for any flexibility or margin of error in the final equilibrium pH. A scheduled process, as defined in 21 CFR 114.3(e), must not permit the growth of microorganisms having public health significance.
The analytical results for the sample that our investigator collected of (Lot # (b)(4)), revealed a hard swell, viable unspeciated mold, seam defects, air bubbles, and food product trapped within seam walls. The pH for sub #1 was (b)(4), and the pH for sub #2 and sub #3 were (b)(4) and (b)(4), respectively. These low pH values may indicate the presence of flat sour organisms which are adversely affecting your product. We are bringing this to your attention in the event that you wish to re-evaluate your process.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct the violations listed in this letter. Your response should include documentation of the corrective actions that you have taken or that you plan to take to correct these violations, including the specifics of what methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If corrective actions cannot be completed within 15 working days of receiving this letter, please state the reason for the delay and include a timetable for the implementation of the remaining corrections.
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions concerning this letter, please contact Compliance Officer Bonner at 215-717-3074 or by email at Lynn.Bonner@fda.hhs.gov.
Sincerely,
/s/
Kirk Sooter
District Director
Philadelphia District
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