Inspections, Compliance, Enforcement, and Criminal Investigations
Frog Island Seafood Inc
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
December 5, 2011
Mr. Robert D. White, Owner
Frog Island Seafood Inc.
3997 Caratoke Highway
Barco, NC 27917
DRAFT WARNING LETTER
(12 – ATL - 03)
Dear Mr. White:
On August 3–4, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility, Frog Island Seafood Inc., located at 3997 Caratoke Highway, Barco, NC. During the inspection, we collected an environmental sample which consisted of multiple swabs taken from a variety of locations within your facility. FDA laboratory analysis of the environmental swabs (sample number 690626) collected during this inspection found the presence of the pathogen Listeria monocytogenes (L. monocytogenes) in your facility, including on food-contact surfaces (copy enclosed). In addition, during our inspection, we observed significant violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). Based on these violations and our finding of L. monocytogenes in your facility, we have determined that the foods manufactured at your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (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 whereby they may have been rendered injurious to health. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
L. monocytogenes is a widespread pathogenic bacterium. Without proper controls, it may be introduced into and proliferate in food manufacturing facilities, where it may contaminate food. Consuming foods that are contaminated with L. monocytogenes may lead to a mild, non-invasive illness known as listerial gastroenteritis or a more severe, sometimes life-threatening, illness known as invasive listeriosis. Pregnant women and their unborn children, infants, the elderly, and persons with weakened immune systems are at greatest risk of experiencing listeriosis, which is characterized by a high case mortality rate and long incubation.
Bacteria may enter and/or be transported through a food plant by a variety of routes that include, but are not limited to: roof leaks; the shoes of employees, contractors, and visitors; the wheels of fork lifts, pallet movers, and moveable equipment; soiled pallets; soiled raw material packaging; raw ingredients; and by various pest vectors. Once established on production area floors, bacteria can contaminate food and food-contact surfaces through either human or mechanical means.
During the inspection, environmental swabs were collected throughout your facility. Six of these environmental swabs tested positive for the pathogen L. monocytogenes. These swabs were collected from: the right side of a floor mat directly below Table 3 in the pick room; the threshold from the picking room into the cooked crab cooler; the red dip basket (a direct food-contact surface) used to shovel crabs and transport cooked crabs to picking tables; standing water found in the left corner of the cooked crab cooler; standing water found in the cooked crab cooler by the exterior door; and the drain located between the west cooked crab cooler door and the retort. The presence of L. monocytogenes on various floor surfaces in your facility is a concern as the bacterium is likely to spread due to employee foot traffic. These positive environmental swabs indicate poor sanitary practices at your facility.
During the inspection, we also documented violations of the CGMP regulation for foods that may lead to the contamination of your products with pathogens, such as L. monocytogenes. Form FDA 483, Inspection Observations, identifying our observations was issued at the close of the inspection (a copy is enclosed for your reference). We acknowledge receipt of your written response dated August 18, 2011, in which you list the corrections you have made. However, we have the following outstanding concern regarding your corrective actions:
In order to comply with 21 CFR 110.20(b)(4), the plant and facilities shall 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. However, our investigators observed condensation in your cooked crab cooler under the air conditioning unit directly above a “wheeled cart” of cooked crabs. Your response indicates that you will no longer place cooked crabs under the cooling unit inside the cooked crab cooler. This corrective action is inadequate in that it does not eliminate the potential for condensate within the cooler to contaminate food, food-contact surfaces, or food-packaging materials. Specifically, your firm has not submitted documentation of any repairs or other measures taken to prevent condensate from falling onto the floor or from directly contaminating the food in the cooler. The “wheeled carts” containing the cooked crabs have mesh bottoms, which facilitate contamination with condensate from the cooler. L. monocytogenes grows very well in wet environments. As mentioned above, four of the swabs that tested positive for L. monocytogenes were collected from your cooked crab cooler or its immediate vicinity.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility. You are responsible for ensuring that your facility and your products are in compliance with the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter and to establish and implement procedures that will prevent such violations from occurring in the future. Failure to do so may result in regulatory action, such as seizure and/or injunction, without further notice.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Please include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please 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: Derek C. Price, Compliance Officer, 60 Eighth Street, NE, Atlanta, GA 30309. If you have any questions about the content of this letter, please contact Mr. Price at 404-253-2277.
Atlanta District Director