Greenhead Lobster Products LLC‘s (Greenhead) ready-to-eat (RTE) seafood processing facility in Bucksport, Maine, suffers from a chronic environmental contamination with Listeria monocytogenes, according to information extracted from US Food and Drug Administration’s website.

The persistent presence of the pathogen in the production environment has been known to the company and the FDA for at least the last two years.

First inspection: 2020

The FDA first visited the Bucksport facility in December 2020, issuing a list of adverse Inspectional Observations (FDA Form 483) upon completion of the inspection.

According to the agency’s inspection citations database, the FDA investigators cited four violations, including:

• Failure to implement the monitoring procedures listed in the company’s HACCP plan;
• Failure of the HACCP plan to list the food safety hazards that are reasonably likely to occur;
• Failure to monitor the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary objects; and
• A corrective action plan not in accordance with regulatory requirements to ensure that a potentially hazardous product is not entered into commerce.

Second inspection: 2021

After giving Greenhead a grace period of several months to bring its food safety programs into compliance, the FDA performed a follow-up inspection in September-October 2021.

During the 2021 inspection, FDA investigators conducted extensive environmental sampling of the facilities production areas, including food-contact surfaces, and found Listeria monocytogenes in a floor drain.

Upon reviewing the company’s environmental monitoring records, the agency noted the presence of thirteen (13) recurring L. monocytogenes positive swabs between May 2021 and August 2021 from the RTE (ready-to-eat) processing room, including eleven (11) swabs collected from food-contact surfaces.

Although the company’s records indicated that the relevant areas were cleaned and sanitized following each positive finding, Greenhead did not conduct any root cause analysis to establish and eliminate the source or sources of the contamination.

Recall #1

On October 2, 2021, while the FDA inspection was still in progress, Greenhead initiated a voluntary product recall, encompassing 5,749 lbs. of frozen cooked lobster meat. The recall cited a “…potential for contamination … noted after a routine sampling program by the company revealed the presence of Listeria monocytogenes.”

Once again, the FDA issued a Form 483 upon completion of the inspection, this time classifying the situation as “Official Action Indicated.”

Warning Letter

On January 24, 2022, after exchanges of communcations regarding the company’s plans for correcting the various deviations, the FDA issued a formal Warning Letter, giving Greenhead a deadline to respond to all outstanding issues.

The Warning Letter reiterated the list of observations included in the Form 483, providing examples to support each item. These included:

• Ongoing serious concerns with the company’s HACCP plan
• Ongoing concerns about the company’s inability to control Listeria monocytogenes in the production environment
• Significant deviations from requirements of the Seafood HACCP plan
• Insufficient monitoring of sanitation conditions and practices during processing
• Inadequate control of the hazard of Clostridium botulinum in high pressure processed (HPP) lobster products.

Third inspection: 2022

In July 2022, the FDA returned to Bucksport yet again to follow up on Greenhead’s response to the Warning Letter.

And yet again, the company’s performance was found wanting.

The Form 483 issued upon completion of the July 2022 inspection listed four main concerns:

• Greenhead’s HACCP plan did not list the food safety hazards that were reasonably likely to occur
• The HACCP plan listed a critical limit that failed to ensure control of one or more hazards
• The company did not take corrective action to prevent potentially hazardous product from entering into commerce, and did not correct the cause of the deviation
• The company was not monitoring sanitation conditions and practices with sufficient frequency to ensure compliance with current Good Manufacturing Practices.

At the close of inspection, company management agreed to make the necessary corrections and the FDA classified the results of the inspection as “Voluntary Action Indicated.”

Fourth inspection: 2023?

Recall #2

Just over one year later, on October 20, 2023, Greenhead announced another voluntary product recall, this time encompassing “…all frozen and refrigerated cooked lobster meat products produced from May 9, 2023, through October 19, 2023.”

The reason given for the recall was the presence of Listeria monocytogenes in the production environment.

Although the environment was contaminated, the pathogen was not found in finished products, and there were no illnesses associated with the recalled products.

The recall encompassed eleven ready-to-eat, refrigerated or frozen lobster products. Please refer to the recall notice for a detailed list of affected products.

The recall notice made no reference to the FDA. Nor has the FDA posted information on a 2023 inspection in its Inspection Citations database.

Nevertheless, past experience suggests that another follow-up inspection is either still in progress or has been completed recently.

What next for Greenhead Lobster Products?

Although constituted as a regulatory agency, the FDA has a history and a philosophy of giving the food companies it regulates multiple chances to self-correct.

Sometimes, this works well. Other times, it does not.

Greenhead has now been inspected on at least three (and possibly four) separate occasions, and its HACCP and sanitation programs were found wanting each time.

The FDA has the power to demand compliance (via a Warning Letter), to mandate recalls (when circumstances demand), and even to shut down a facility by suspending its registration.

Except for the issuance of a Warning Letter, the agency rarely makes use of these regulatory powers.

Will Greenhead prove to be one of those rare occasions, or will the FDA sit on its hands until one or more illnesses are linked to the company’s products?

Stay tuned.

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