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.

Greenhead Lobster Products LLC
Bucksport, ME

A food firm in Maine is on notice from the FDA for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and for the discovery of Listeria monocytogenes in their facility.

In a Jan. 24 warning letter, the FDA described a Sept. 21-23, 27 and 30, and Oct. 6, 2021, inspection of  Greenhead Lobster Products ready-to-eat (RTE) seafood processing facility in Bucksport, ME.

The FDA’s inspection revealed that the firm was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483.

Some of the firm’s significant violations are as follows:

Presence of Listeria monocytogenes
FDA laboratory analysis of the environmental sample 1166292 collected on Sept. 21, 2021, during the production of RTE cooked lobster, confirmed 1 out of 99 environmental swabs collected was positive for Listeria monocytogenes. The positive swab (Sub 98) was collected from a floor drain cover adjacent to the firm’s picking/cracking station where lobsters are prepared prior to cooking. 

Also, 2 swabs collected from the outside surface of their cooling tank were found positive for Listeria monocytogenes on Aug. 3 and 25, 2021.

The firm’s records indicated that they cleaned and sanitized each of these areas; however, the FDA notes that they did not conduct a root cause investigation at the time sample results were received to determine the source of the contamination. On Oct. 2, 2021, after the FDA presented their concerns with the positive Listeria monocytogenes findings, the firm conducted a voluntary recall of all frozen RTE lobster products that were in contact with these Listeria monocytogenes positive surfaces. 

Seafood HACCP
Some of the firm’s significant deviations are as follows:

  1. The firm must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point. However, the firm’s HACCP plan for RTE vacuum-packed cooked lobster meat lists a monitoring procedure and frequency at the cooking critical control point that is not adequate to control the food safety hazard of pathogenic bacteria survival through cooking.

Specifically, the firm’s HACCP plan lists a monitoring procedure for checking the internal lobster temperature (redacted) during production. (Redacted) internal product temperature (EPIPT) monitoring strategy. FDA recommends that they perform EPIPT monitoring at least every 30 minutes, and whenever any changes in product-heating critical factors occur. This increase in monitoring frequency (redacted) to every 30 minutes is to ensure that the lobster meat exiting the continuous cooker achieves a minimum 6 log reduction of Listeria monocytogenes to control the hazard of pathogens surviving the cooking process in their RTE cooked lobster products.

  1. The firm must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements, that are appropriate to their plant and the food being processed and relate to one of the areas specified.
  2. The firm did not monitor the conditions and practices during processing with sufficient frequency to ensure that drip or condensate from fixtures, ducts and pipes does not contaminate food. This is related to the protection of food from adulteration with condensate. Specifically, FDA investigators observed a buildup of condensate on the ceiling above exposed RTE cooked lobster meat in the processing room.
  3. The firm did not monitor the conditions and practices during processing with sufficient frequency to ensure that their plant’s plumbing was adequately maintained to provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor. This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food-contact surfaces. Specifically, condensate from an evaporator catch-bucket was overflowing onto the cooler floor. This was a repeat observation from the previous inspection, as condensate was previously observed to drain directly onto the floor of the cooler, and the firm’s corrective action was to place a bucket underneath to be emptied as necessary.

The full warning letter can be viewed here.

Rainfield Marketing Group Inc.
Vernon, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a Nov. 3 warning letter, the FDA described a June 15 remote Foreign Supplier Verification Program (FSVP) inspection of Rainfield Marketing Group, Inc. in Vernon, CA.

The inspection was initiated after Listeria monocytogenes was found in a sample of enoki mushrooms from (redacted) in Korea, collected by the California Department of Public Health (CDPH), and imported by the firm. The FDA acknowledges that the firm initiated a voluntary recall of their enoki mushrooms. On July 21, 2021, enoki mushrooms from (redacted) were placed on Import Alert # 99-21 Detention Without Physical Exam of Produce Due to Contamination With Human Pathogens.

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.

Some of the firm’s significant violations of the FSVP regulation are as follows:

The firm did not develop, maintain, and follow an FSVP for any of the foods they import, including the following foods:

  • Perilla leaves imported from their foreign supplier (redacted) located in (redacted)
  • Strawberries imported from their foreign supplier (redacted) located in (redacted)
  • Strawberries imported from their foreign supplier (redacted) located in (redacted)
  • Strawberries imported from their foreign supplier (redacted) located in (redacted)
  • Garlic bulb imported from their foreign supplier (redacted) located in (redacted)
  • Grapes imported from their foreign supplier (redacted) located in (redacted)
  • Cilantro imported from their foreign supplier (redacted) located in (redacted)
  1. The firm’s onsite audit of their foreign suppliers did not include the required verification activities. Specifically, their onsite audit did not consider the applicable food safety regulation and a review of the foreign supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled. For their foreign suppliers, (redacted) Korea for enoki mushroom, (redacted) Korea for king oyster mushroom, and (redacted) for spinach, their verification activities did not consider applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations.

Enoki mushrooms, king oyster mushrooms, and spinach are “covered produce” as defined in federal law and therefore must comply with FDA’s Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Food Safety Modernization Act (FSMA) Produce Safety Rule) regulation. None of the records the firm provided show their foreign suppliers considered this regulation or processes and procedures that provide at least the same level of public health protection as the applicable food safety regulation.

  1. The firm did not retain documentation of each sampling and testing of a food, including identification of the food tested (including lot number, as appropriate), the number of samples tested, the test(s) conducted (including the analytical method(s) used), the date(s) on which the test(s) were conducted and the date of the report of the testing, the results of the testing, any corrective actions taken in response to detection of hazards, information identifying the laboratory conducting the testing, and documentation that the testing was conducted by a qualified individual. Specifically, the firm did not retain documentation of the number of samples tested, of the test(s) conducted, and that the testing was conducted by a qualified individual, in accordance with their written procedure per 1.506(b), titled “Supplier Verification Plan and Record” dated June 28, 2021. The firm submitted certificates of laboratory testing for enoki mushrooms dated March 31, 2021, for receipt no. (redacted) and certificates of laboratory testing dated April 13, 2021, for receipt no. (redacted) as documentation of their verification activity for (redacted). However, those certificates of laboratory testing did not identify the number of samples tested, the test method(s), or the qualification of the individual that conducted the testing.

The full warning letter can be viewed here.

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