| 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
October 20, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
and VIA FACSIMILE TRANSMISSION
In reply refer to Warning Letter SEA 12-02
Jimmie L. Davis, President
Snokist Growers
P.O. Box 1587
Yakima, Washington 98907
WARNING LETTER
Dear Mr. Davis:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility located at 2506 Terrace Heights Drive, Yakima, Washington, from May 3, 2011, through June 2, 2011. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that the food products were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
FDA acknowledges the receipt of your response letter to the form FDA-483, Inspectional Observations, dated June 22, 2011.
The significant violations were as follows:
1. To comply with 21 CFR 110.80(b)(9), if you recondition food that is adulterated within the meaning of the Act you must use a method proven to be effective, or you must reexamine the food and determine it is no longer adulterated. However, your firm reprocesses moldy applesauce product contained in compromised aseptically packaged flexible laminated bags using a method that is not effective against all toxic metabolites produced from the mold, and does not reexamine the food and determine it is no longer adulterated. Several foodborne molds may be hazardous to human health because of their ability to produce toxic metabolites known as mycotoxins. Most mycotoxins are stable compounds that are not destroyed by heat treatment. Even though the generating organisms may not survive the heat treatment, the preformed toxin may still be present.
Eight instances were identified in your firm's records, from January 2010 through December 2010, where your firm reprocessed organic apple puree and applesauce due to mold using a method that is not effective against all toxic metabolites produced from the mold, and did not reexamine the food and determine it was no longer adulterated:
a) On January 13, 2010, nine totes of organic apple puree were reprocessed into #10 cans due to the presence of white and/or brown mold.
b) On January 14, 2010, 13 totes of organic apple puree were reprocessed into #10 cans due to the presence of white, brown, and/or green mold.
c) On January 15, 2010,18 totes of organic apple puree were reprocessed into #10 cans due to the presence of white and/or brown mold.
d) On January 21, 2010,12 totes of organic apple puree were reprocessed into #10 and 15-ounce cans due to the presence of white and/or brown mold.
e) On January 22, 2010,15 totes of organic apple puree were reprocessed into #10 cans and 15-ounce cans due to the presence of white, brown, and/or green mold.
f) On January 26, 2010, two totes of applesauce and three totes of organic apple puree were reprocessed into 15-ounce cans due to the presence of black, green, and/or white mold.
g) On February 26, 2010, one tote of applesauce and seven totes of organic apple puree were reprocessed into #10 cans due to the presence white, brown, and/or gray mold.
h) On December 10, 2010, seven totes of organic apple puree were reprocessed into #10 cans due to the presence of white, brown and/or green mold.
In your response letter dated June 22, 2011, you provided a revised Rework Policy, dated June 21, 2011. We acknowledge that you now plan to conduct patulin testing for any product that exhibits mold contamination. Your Rework Policy does not address how you will reexamine reconditioned/reworked product for other preformed toxic metabolites that cannot be destroyed by heat treatment.
2. You must take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, to comply with 21 CFR 110.80. Under 21 CFR 110.80(b)(13), filling, assembling, packaging, and other operations must be performed in a manner that protects food against contamination. Specifically, the following was observed in your facility:
a) Overlap measurement records for the double seam structure of #10 cans of applesauce indicate that you were not meeting the can manufacturer's specifications for minimum overlap on several production days. There was no documentation that any corrective action was made or that any seamer adjustments occurred.
b) A pallet containing several leaking cans of plums, and rows of pallets with numerous leaking cans of diced pears were observed in warehouse (b)(4).
c) Pallets of leaking cans of unsweetened applesauce, diced pears, dark sweet cherries, and pear halves were observed in warehouse (b)(4).
d) Pallets of leaking and corroded cans of unsweetened applesauce and pears were observed in warehouse (b)(4)
In your response letter dated June 22, 2011, you stated that you will monitor double seaming operations, hold any nonconforming product for evaluation, and that you have developed a log and written procedure. The adequacy of these corrective actions and their implementation will be assessed during our next inspection.
3. To comply with 21 CFR 110.20(b)(4), your plant and facilities must be constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food packaging materials. Specifically, the following conditions were observed in your facility:
a) Condensate was observed on a water line located above the apple slice conveyor.
b) Condensate was observed on a water drain line located above the apple slice conveyor.
c) Non food grade hydraulic fluid was observed dripping from a pipe onto the housing of the apple slice conveyor.
In your response letter dated June 22, 2011, you stated that you would cover the contact areas or use an appropriate means to prevent condensate from forming and contaminating food or food contact surfaces. You also stated that you will now monitor for hydraulic leaks during plant inspections and replace the current hydraulic fluid with a food grade fluid. The adequacy of these corrective actions and their implementation will be assessed during our next inspection.
4. To comply with 21 CFR 110.37(e), hand-washing facilities are to be adequate and convenient and furnished with running water at suitable temperatures. There were no hand-washing facilities located in your production area; therefore, employees were not able to conveniently wash their hands before starting work and after each absence from the workstation.
In your response letter dated June 22, 2011, you stated you will install wash stations in the apple processing facility before the start of the next processing season. The adequacy of this corrective action and its implementation will be evaluated during our next inspection.
5. To comply with 21 CFR 110.35(b)(2), sanitizing agents must be held in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. However, a hand sanitizer dispenser was observed in your facility located above open empty applesauce cups on the apple cup fill line while the line was operating.
In your response letter dated June 22, 2011, you stated that you immediately corrected this deficiency and that inspection personnel will be trained to specifically look for and correct any similar situation in the future. The adequacy of these corrective actions and their implementation will be evaluated during our next inspection.
6. To comply with 21 CFR 110.40(a), food contact surfaces must be maintained to protect food from contamination by any source. However, disintegrating and flaking plastic diverters used to divert sliced apples into the vacuum tank were observed in direct contact with apple slices in your facility.
In your response letter dated June 22, 2011, you stated that you will replace the apple diverters and that personnel will be trained to specifically look for and correct any similar situation in the future. The adequacy of these corrective actions and their implementation will be evaluated during our next inspection.
7. To comply with 21 CFR 110.37(b)(3), plumbing shall be of adequate size and design and adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition. Specifically, the following was observed in your facility:
a) The outlet of a potable water line terminates approximately one inch below the flood level of the "final hold tank" in the applesauce production area. Applesauce is held in the final hold tank" prior to being dispensed into finished product cans.
b) The outlet of a potable water line terminates approximately one inch below the flood level of "TANK (b)(4)" in the applesauce production area. Syrup and flavoring is held in "TANK (b)(4)" prior to being mixed with applesauce.
In your response letter dated June 22, 2011, you stated that the outlet of the potable water line has been moved. The adequacy of this corrective action and its implementation will be evaluated during our next inspection.
8. To comply with 21 CFR 110.35(c), effective measures must be taken to exclude pests from the processing areas and to protect against contamination of food. Pest activity was observed in several of your warehouses, as evidenced by the following:
a) At least 10 live fruit flies were observed flying near and landing on sliced apples from a burst can in row (b)(4)
b) At least seven live fruit flies were observed in row (b)(4) on a pallet of leaking cans.
c) At least 20 dead fruit flies were observed directly adjacent to a can on the cardboard slip of the bottom layer of cans on a pallet in row (b)(4)
d) At least 20 live fruit flies were observed flying around and landing on a leaking can in row (b)(4)
e) At least three live fruit flies were observed flying near and landing on leaking cans on one pallet in row (b)(4)
f) At least three live fruit flies were observed in a broken jar of product in row (b)(4).
g) Four apparent insect larvae were observed on a cardboard slip directly adjacent to the bottom of a leaking can in row (b)(4).
h) Two bird feathers were observed along the north wall of row (b)(4)
i) One bird feather was observed on the floor in row (b)(4).
j) Bird excreta was observed on the wall, near the ceiling wall juncture, at the end of row (b)(4). One bird feather was also observed on the floor adjacent to the wall at the end of row (b)(4).
In your response letter dated June 22, 2011, you described your efforts to eliminate pests from the facility, and your sanitation audits. The adequacy of these corrective actions and their implementation will be evaluated during our next inspection.
9. To comply with 21 CFR 110.20(b)(7), adequate screening or other protection must be provided against pests. Specifically, the following was observed in your facility:
a) A gap measuring approximately 1" x 8" exists along the base of the door screen for door 12 in Warehouse (b)(4).
b) A gap measuring approximately 2" x 8" exists in the window screen of the men's toilet room.
c) The window in the women's toilet room was open and not screened. The open window was approximately 12" x 36."
d) A gap exists at the floor wall junction, approximately 2" in diameter, leading to the exterior of the facility in the north east corner of Warehouse (b)(4) in row (b)(4)
e) A gap exists measuring 1/2" to 1/4" under a closed door, leading directly to the exterior of the facility in the north east comer of Warehouse (b)(4)
In your response letter dated June 22, 2011, you stated that you have sealed all gaps. The adequacy of these corrective actions and their implementation will be evaluated during our next inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring that your manufacturing facility operates in compliance with the Act and its implementing regulations.
Failure to implement lasting corrective action for these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
Please notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa Althar at (425) 483-4940.
Sincerely,
/S/
Charles M. Breen
District Director
No comments:
Post a Comment