FDA Warns Companies of Import Violations and Listeria in Ready-to-Eat Seafood Facilities

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As part of its enforcement activities, the Food and Drug Administration issues warning letters to entities under its jurisdiction. Some letters are not displayed to the public until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until a company has had months or even years to correct the issues. The FDA frequently redacts portions of warning letters posted to the public.


Greenhead Lobster Products LLC
Bucksport, ME

A food company in Maine is warned by the FDA for violating the seafood Hazard Analysis and Critical Control Point (HACCP) and for the discovery of Listeria monocytogenes in their establishment.

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

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

Some of the company’s significant violations are:

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

Additionally, 2 swabs taken from the outer surface of their cooling tank tested positive for Listeria monocytogenes August 3 and 25, 2021.

Company records indicated that they had cleaned and disinfected each of these areas; however, the FDA notes that it did not conduct a root cause investigation at the time the sample results were received to determine the source of the contamination. On October 2, 2021, after the FDA raised concerns about the positive Listeria monocytogenes findings, the company has voluntarily recalled all frozen RTE lobster products that have come into contact with these Listeria monocytogenes positive surfaces.

HACCP seafood
Some of the firm the significant differences are as follows:

  1. The company must have a HACCP plan which, at a minimum, lists the monitoring procedures and their frequency for each critical control point. However, the company’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 the meat. survival of pathogenic bacteria during cooking.

Specifically, the company’s HACCP plan lists a monitoring procedure to verify the internal temperature of lobster (redacted) during manufacturing. (Redacted) Internal Product Temperature Monitoring Strategy (EPIPT). The FDA recommends performing EPIPT monitoring at least every 30 minutes and whenever changes in critical product heating factors occur. This increase in monitoring frequency (redacted) every 30 minutes is to ensure that the lobster meat exiting the continuous cooker achieves a minimum reduction of 6 log of Listeria monocytogenes control the danger posed by pathogens surviving the cooking process in their RTE cooked lobster products.

  1. The company must monitor hygienic conditions and practices during processing with sufficient frequency to ensure compliance with current requirements of good manufacturing practices, which are appropriate to their plant and the food being processed and relate to one of the specified areas.
  2. The company did not monitor conditions and practices during processing with sufficient frequency to ensure that drips or condensate from fixtures, ducts and pipes did not contaminate food. This is related to protecting the food from adulteration with the condensate. Specifically, FDA investigators observed a buildup of condensate on the ceiling above the exposed RTE cooked lobster meat in the processing room.
  3. The company did not monitor conditions and practices during processing with sufficient frequency to ensure that its plant plumbing was properly maintained to provide adequate soil drainage in all areas where soils are subject to flood-type cleaning or when normal operations release or discharge water or other liquid waste onto the floor. This is related to the prevention of cross-contamination of unsanitary objects with food, food packaging materials and other food contact surfaces. Specifically, condensate from an evaporator drain bucket overflowed onto the chiller floor. This was a repeat observation from the previous inspection, as the condensate had previously been observed to drain directly onto the chiller floor, and the company’s corrective action was to place a bucket underneath to empty it if necessary.

The full warning letter can be viewed here.

Rainfield Marketing Group Inc.
Vernon, California

An import company in California is warned by the FDA that it does not have an FSVP for a number of imported food products.

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

The inspection started 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 company has issued a voluntary recall of its enoki mushrooms. On July 21, 2021, enoki mushrooms from (redacted) have been placed on Import Alert #99-21 Detention without Physical Examination of Products due to contamination with human pathogens.

The FDA inspection revealed that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

Some of the significant violations of FSVP regulations by the company are:

The company has not developed, maintained, and tracked an FSVP for any of the foods it imports, including the following foods:

  • Perilla leaves imported from their foreign supplier (redacted) situated in (redacted)
  • Strawberries imported from their foreign supplier (redacted) situated in (redacted)
  • Strawberries imported from their foreign supplier (redacted) situated in (redacted)
  • Strawberries imported from their foreign supplier (redacted) situated in (redacted)
  • Garlic bulb imported from their foreign supplier (redacted) situated in (redacted)
  • Grapes imported from their foreign supplier (redacted) situated in (redacted)
  • Coriander imported from their foreign supplier (redacted) situated in (redacted)
  1. The company’s on-site audit of its foreign suppliers did not include the required verification activities. Specifically, their on-site audit did not consider applicable food safety regulations or a review of the foreign supplier’s written food safety plan, if any, and its implementation, for the controlled hazard. 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 or information regarding the foreign supplier’s compliance with such regulations.

Enoki mushrooms, king oyster mushrooms and spinach are “covered products” as defined in federal law and therefore must comply with FDA standards for growing, harvesting, packaging and storing products intended for human consumption (Food Safety Modernization Act (FSMA). Product Safety Rule) regulation. None of the records provided by the company show that its foreign suppliers have 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 company did not keep documentation of each sampling and analysis of a food, including identification of the food tested (including lot number, if applicable), number of samples tested, the test(s) performed (including analytical method(s) used), the date(s) the test(s) were performed and the date of the test report, test results, any corrective action taken in response to the hazard detection, information identifying the laboratory performing the testing, and documentation that the testing was performed by a qualified person. Specifically, the company did not keep documentation of the number of samples tested, which test(s) were performed, and that the tests were performed by a qualified person, in accordance with their written procedure under 1.506 ( b), titled “Vendor Verification Plan and Record” dated June 28, 2021. The company submitted laboratory testing certificates for enoki mushrooms dated March 31, 2021, for receipt no. (redacted) and laboratory test certificates dated April 13, 2021, for receipt no. (redacted) as documentation of their verification activity for (redacted). However, these laboratory test certificates did not indicate the number of samples tested, the test method(s) or the qualification of the person who performed the tests.

The full warning letter can be viewed here.

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