Nachman's Native Seafood 2/9/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Florida District 555 Winderley Place, Suite 200 Maitland, Florida 32751 Telephone: 407-475-4700 FAX: 407-475-4770

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
FLA-11-15
February 9, 2011

Mr. Leonard K. Nachman
President
Nachman's Native Seafood
17811 Gulf Blvd.
Redington Shores, FL 33708

Dear Mr. Nachman:

The United States Food and Drug Administration (FDA) inspected your seafood processing facility, located at the above address from October 28, 2010 to November 5, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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)]. Accordingly, your ready to eat Smoked Fish Spread is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must implement the record-keeping system you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the receiving, thawing, cooking and refrigeration storage critical control points (CCPs) to control various seafood hazards as listed below in your product specific HACCP planes) as follows:

• HACCP plan for Fresh Fish Receiving: No monitoring records were observed to be filled out indicating receipt of fresh fish and none were available for review.

• HACCP plan for Smoked Fish

o Thawing: No "Temperature Report" for temperature monitoring or "Waste Report" for excessive thaw time was observed to be checked or available for review.

o Cooking: No "Smoked Fish Report" stating the type of fish, amount of time smoked, smoking temperature and final internal temperature was observed to be filled out or was available for review.

o Refrigerated storage: No "Temperature Report" for continuous monitoring of cooler temperature was observed or available for review. Cooler temperature at the time of the inspection was not undergoing continuous monitoring.

• HACCP plan for Smoked Fish Spread

Refrigerated. Smoked Fish Spread room: No "Temperature Report" for continuous temperature monitoring of room was observed to be filled out or available for review.

2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following specific areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:

a) Conditions were found at your firm which afforded the possibility of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product in violation of 21 CFR 123.11(b)(3). Examples of these conditions observed during the current FDA inspection were:

• The (b)(4) grinder and mixer located in the smoked fish processing room had a buildup of organic matter on its surfaces including switches and dials and had not been adequately cleaned and sanitized.

• The ice storage tote located in the Smoked Fish Spread processing room used for the storage of finished Smoked Fish Spread had

o an accumulation of organic buildup around the inside rim of the tote; and

o an accumulation of mildew on the inside surface of the tote cover.

• There was a mildew accumulation

o in your smoked fish processing room on the rear wall and ceiling surfaces;

o on the vinyl separator strips at the doorway of the fish spread room; and

o on the cooling fans in the fish spread room between the gratings on each of the two plastic fan covers.

b) Your processing facility was found lacking in construction such that floors, walls, and ceilings were not adequately cleaned and kept clean and kept in good repair as required by 21 CFR 110.20(b)(4). Examples of these conditions observed during the current FDA inspection were:

• A wall within the fish filleting room and adjacent to the fish filleting table was observed to have chipping paint in need of repair and is not easily cleaned and sanitized.

• Our investigator's observed a hole adjacent to the toilet which exposes plumbing and a hole in the ceiling with exposed electrical fixtures.

• The restroom is not equipped with a self closing door.

We recognize the voluntary corrections you made during the inspection, such as the cleaning of the mildew in the areas identified above, and the cleaning of the fish tote, however we believe these sanitation issues need to be addressed in your normal sanitization and cleaning schedule to prevent your ready to eat Smoked Fish Spread from becoming contaminated with filth or bacteriological pathogens during processing.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records 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.

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, the Seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.

Sincerely,
/S/
Emma R. Singleton
Director, Florida District
 

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