Mr. Robert Martin
- Wild Edibles Inc.
740 Barry Street
Bronx, NY 10474
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
December 18, 2014
WARNING LETTER NYK-2015-15
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Robert Martin, President
Wild Edibles, Inc.
740 Barry Street
Bronx, New York 10474
Dear Mr. Martin:
We inspected your seafood processing facility, located at 740 Barry Street, Bronx, New York on September 10 and 12, 2014.
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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 marinated anchovies in oil, smoked salmon in reduced oxygen packaging, pasteurized canned crab and histamine species (yellowfin tuna, mahi mahi, bluefish and mackerel) are
adulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby theymay 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 conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b). However your firm does not have a HACCP plan for the refrigerated ready to eat fishery products of marinated anchovies in oil, smoked salmon in reduced oxygen packaging, pasteurized canned crab meat in reduced oxygen packaging, whitefish salad, and smoked salmon salad to control the food safety hazards of undeclared allergens, pathogen growth and toxin formation including Clostridium botulinum due to time/temperature abuse.
2. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan, that at minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for yellowfin tuna, mahi mahi, bluefish and mackerel, which lists that it may be eaten raw, partially or fully cooked, does not list the food safety hazard of parasites in raw (not frozen) mackerel.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However your firm’s HACCP plan for yellowfin tuna, mahi mahi, bluefish and mackerel does not list adequate monitoring procedures at the (b)(4) and (b)(4) critical control points to control the food safety hazards of pathogen growth in a ready to eat food and scombrotoxin (histamine) formation. Specifically, for the (b)(4) and (b)(4) critical control points (CCP), the listed monitoring procedure of recording product temperature is not appropriate when the critical limit is (b)(4) Your plan should list visual monitoring of the presence of adequate ice in a representative number of containers throughout the cooler. Furthermore, your (b)(4) indicates that your firm monitors ice at receiving and storage by checking yes or no. However, the monitoring logs for checking the adequacy of ice should indicate the checking of multiple containers from various places throughout the cooler. The number of containers checked should be based on the total number of containers in the lot and be a representative sample of the entire lot.
4. Corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, at the critical control point for (b)(4) your listed corrective action of (b)(4) is not adequate to control the hazards of pathogen growth in a ready to eat food and scombrotoxin (histamine) formation. In addition to rejecting the product, FDA recommends addressing the root cause of the deviation, such as discontinuing use of the supplier until evidence is obtained that the transportation-handling practices have been improved.
Additionally, at the critical control point for (b)(4) your listed corrective action of (b)(4) is not adequate to control for the hazards of pathogen growth in a ready to eat food and scombrotoxin (histamine) formation. Since your firm is only monitoring the adequacy of ice twice a day, it is not possible to accurately determine the time that the fish were not adequately iced or the exposure temperatures. The only option for disposition of the product with your current monitoring frequencies is to reject or destroy the affected product. If your firm chooses to monitor cooler temperatures continuously with a data logger, then evaluating the exposure times and temperatures to determine product safety can be an option as a corrective action. Your firm must address both pathogen growth and histamine formation as part of your corrective actions since safe time and temperature exposures vary for these two hazards.
5. 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 safety of water than comes into contact with food or food contact surfaces, including water used to manufacture ice, with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110. Specifically,
- Ice was observed chuting from your ice maker, located above your ceiling, directly onto the concrete floor of your fish warehouse and processing room. This ice is used directly on whole and processed fish that are intended to be eaten raw or partially cooked.
- Condensate was observed dripping from the ceiling and lighting above your ice storage area. Ice was observed stored under this drip which is used on whole and processed fish that are intended to be eaten raw or partially cooked.
6. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b) to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the condition and cleanliness of: food contact surfaces, including utensils, gloves, and outer garments; prevention 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; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; proper labeling, storage and use of toxic compounds; control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and exclusion of pests from the food plant, as required for the processing of fishery products, including your ready-to-eat/intended to be eaten raw histamine species fish. Specifically, sanitation control records were not maintained for September 8, 9 &10, 2014.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) 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 Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)).For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The April 2013 inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to: Lillian C. Aveta, Compliance Officer, New York District Office, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail at firstname.lastname@example.org.
Ronald M. Pace
New York District
Director, Seafood Safety Inspection Program
USDC, NOM, NMFS
1315 East-West Highway
Silver Spring, MD 20910
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