As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
J & L USA Inc.
Commerce, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an April 30 warning letter, the FDA described a Jan.19, 2021, remote Foreign Supplier Verification Program (FSVP) inspection for J & L USA Inc. The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The firm’s significant violations of the FSVP regulation are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for any of the foods they import, including but not limited to, the following foods:
- Green Tea imported from (redacted), located in (redacted)
- Dried Bamboo Leaf imported from (redacted), located in (redacted)
- Dried White Fungus imported from (redacted), located in (redacted)
- Rock Candy imported from (redacted), located in (redacted)
- Brown Candy in Pieces imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
Martinez Produce & Seafood Inc
Chicago, IL
A food firm in Chicago is on notice from the FDA for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In an April 28 warning letter, the FDA described a Jan. 5 through 14, 2021, inspection at Martinez Produce & Seafood Inc.’s seafood processing facility and importer establishment. FDA inspectors found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, resulting in the issuance of an FDA Form 483.
The firm’s significant violations are as follows:
- The firm must conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur and they must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur. However, the firm does not have a HACCP Plan for fresh tuna and salmon in reduced oxygen packaging to control the hazard of Clostridium botulinum growth and toxin formation, distributed directly to consumers through online sales. Specifically, FDA investigators observed the processing of small portions of tuna which were vacuum packed in reduced oxygen packaging (ROP) for distribution. When asked if the firm had a HACCP plan for ROP processed seafood, their employee stated the firm did not currently have a HACCP plan for ROP fin fish.
The FDA has reviewed their corrective action of discontinuing the practice of vacuum packaging their fresh seafood, including fresh tuna and salmon products. In their response, the firm states that they now use (redacted) freezer bags to package their fresh seafood. If implemented correctly, this corrective action should be sufficient to address the hazard of Clostridium botulinum growth and toxin formation.
- The firm must implement an affirmative step which ensures that the fish and fishery products they import are processed in accordance with the seafood HACCP regulation. However, the firm does not have nor has implemented an affirmative step for Tuna (imported from (redacted)), mackerel (imported from (redacted)), and Flounder fish (imported from (redacted)). Specifically, when FDA investigators asked to review their affirmative step documents, their employee stated they did not currently have an import verification program. In addition, the same employee stated they were unfamiliar with their suppliers’ operations and do not have any information for the control of hazards in the seafood products imported from their suppliers.
The FDA has reviewed their corrective action which included the creation of a “Foreign Supplier HACCP USA-FDA Compliance Form”, requesting suppliers to provide the date of their last FDA inspection, certification that they are following GMPs, and SSOPs, as well as, their most current “USA-Compliant” HACCP plan.
- The firm must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice requirements, that are appropriate to their plant and the food being processed and related to one of the areas specified in 21 CFR 123.11(b)(1) — (8). However, the firm did not monitor the following conditions and practices with sufficient frequency to ensure compliance.
- a) The firm did not monitor conditions and practices with sufficient frequency to ensure that they clean and sanitize their utensils or equipment in a manner that protects against contamination. Specifically, FDA investigators observed their cleaning and sanitization of knives used to cut ready-to-eat blue fin tuna. The firm’s employee dipped the knives in a (redacted) solution, wiped the solution off, and then placed the knives into a smaller grey plastic container filled with a (redacted) Once placed in the grey plastic container, the knives are considered ready for use. No detergent was used during cleaning. Visible residual food debris was observed on the knives after their cleaning and sanitizing activities.
- b) The firm did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination. Specifically, FDA investigators observed cleaning operations in the refrigerated processing room where whole, ready-to-eat blue fin tuna and open boxes of ready-to-eat salmon were stored. Multiple employees were observed using high-pressure hoses to remove debris from food contact surfaces, the floor, and the floor drains adjacent to the ready-to-eat tuna and salmon.
The full warning letter can be viewed here.
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