| Public Health Service Food and Drug Administration |
Baltimore District Office |
Department of Health and Human ServicesWARNING LETTER
(b)(4)
October 21, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. John A. Warhime, CEO/Chairman
Hanover Foods Corporation
P.O. Box 334
Hanover, Pennsylvania 17331
Dear Mr. Warhime:
The Food and Drug Administration (FDA) conducted an inspection of your produce manufacturing facility, located at 502 Factory Lane, Hanover, Maryland from April 6 to April 30, 2009 and from May 11 to May 27, 2010. During the inspection, FDA collected a number of samples. Laboratory analyses of these samples found the presence of the pathogen Listeria monocytogenes (L. mono) in environmental and in-line samples. In addition, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These observations and the results of the laboratory analysis cause the foods manufactured at your facility to be adulterated under 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act), in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov.
During the inspection, FDA collected samples of in-line sliced mushrooms, and environmental swabs and sponges taken from throughout your processing facility, including the Individually Quick Frozen (IQF) room. Laboratory analysis of the samples confirmed the presence of L. mono in a sliced mushroom in-line sample and in an environmental sample from a food contact surface. The finding of L. mono in a sliced mushroom in-line sample, and on food contact surfaces in your facility indicates a high risk of finished product contamination.
L. mono is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility. L. mono can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Listeriosis is an atypical foodborne illness of major public health concern because of the severity of the disease, a high case-fatality rate, a long incubation and a predilection for individuals with underlying conditions.
Our investigators documented a number of significant objectionable conditions relating to your facility’s compliance with the CGMP regulations. Significant deviations observed during the inspection include:
1. Your firm failed to take effective measures to protect finished food from contamination by ingredients or refuse, and failed to protect food transported by conveyor against contamination as required by 21 CFR 110.80(b)(6). Specifically, the following was observed during the inspection:
A. Ready-to-eat mushrooms were observed spilling from the hopper affixed to the conveyer belt in the IQF room onto an electrical panel accumulated with old food debris. After the mushrooms spilled onto the electrical panel accumulated with old food debris they bounced into a 40lb box containing ready-to-eat mushrooms.
B. Accumulated mushroom debris was observed caught between the conveyer belt and conveyer belt wheel. The accumulated mushroom debris was observed being sprinkled into open boxes containing ready-to-eat mushrooms in the IQF room.
C. Defrosted mushroom debris was observed accumulated on the following pieces of equipment during operation and coming in contact with the rotating conveyer belt carrying ready-to-eat mushrooms to be packed:
a) Cross beam beneath the magnet as mushrooms exit from the IQF freezer.
b) Scraper located beneath the magnet as mushrooms exit from the IQF freezer.
c) Metal guide affixed to magnet as mushrooms exit from the IQF freezer.
2. Your firm failed to take effective measures to protect against the inclusion of metal or other extraneous material in food as required by 21 CFR 110.80(b)(8). Specifically, an accumulation of rust was observed on multiple bolts affixed to a grow rack containing wheat grass in the “Green Sprout Grow Room.” The bolts were observed to be dripping water that accumulated on them from the grow rack's watering system. The rusty bolts were located directly over multiple pans containing in-process (growing) wheat grass.
3. Your firm failed construct your facility in such a manner that drip or condensate from fixtures does not contaminate food as required by 21 CFR 110.20(b)(4). Specifically, two 55 gallon drums that contained ready-to-eat alfalfa sprouts were observed stored uncovered under a water hose reel that was affixed to the wall of the “Sprout Washroom.” The water hose reel was accumulated with water and water droplets were observed dripping into the drums that contained uncovered ready-to-eat alfalfa sprouts.
4. Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the following was observed during the inspection:
A. The receiving door located on the western wall of the “Dry Warehouse” had three gaps leading to the exterior of the firm.
B. The northern wall of the “Green Bean Room” had a gap which led to the exterior of the firm.
C. The exit door on the southern wall of the “Green Bean Room” had a gap which led to the exterior of the firm.
We have reviewed your June 9, 2010 response letter to the FDA-483 from Bridget Dadds, QC Management. Although your letter states that a number of corrective actions have been completed, the actions outlined in your response letter have not fully addressed all our concerns. Please submit documentation which shows completion of corrections (i.e., revised SSOPs, photographs or receipts that verify equipment or other structural modifications, etc.) and steps you have taken to prevent contamination of finished products with L. mono. The adequacy and implementation of your corrective actions and will be assessed during our next inspection.
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 the CGMP regulations (21 CFR Part 110). You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions since your June 2010 correspondence, including any further specific steps that you have taken to correct violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Randy F. Pack, Compliance Branch Director at the address above. If you have questions regarding any issues in this letter, please contact Mr. Pack at (410) 779-5417.
Sincerely,
/s/
Evelyn Bonnin
District Director
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