As phase of its enforcement activities, the Meals and Drug Administration sends warning letters to entities below its jurisdiction. Some letters are no longer posted for public eye unless weeks or months after they’re sent. Enterprise householders contain 15 days to acknowledge to FDA warning letters. Warning letters assuredly are no longer issued unless a firm has been given months to years to correct considerations. The FDA continually redacts parts of warning letters posted for public eye.


Greenhead Lobster Merchandise LLC


Bucksport, ME

A food company in Maine is on plot from the FDA for violations of the seafood Hazard Prognosis and Serious Retain an eye on Level (HACCP) law and for the invention of Listeria monocytogenes of 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 Merchandise ready-to-eat (RTE) seafood processing facility in Bucksport, ME.

The FDA’s inspection revealed that the company modified into no longer in compliance with FDA regulations and resulted in the issuance of an FDA Possess 483.

One of the most most company’s main violations are as follows:

Presence of Listeria monocytogenes


FDA laboratory diagnosis of the environmental sample 1166292 accrued on Sept. 21, 2021, in the end of the production of RTE cooked lobster, confirmed 1 out of 99 environmental swabs accrued modified into certain for Listeria monocytogenes. The certain swab (Sub 98) modified into accrued from a ground drain duvet adjoining to the company’s selecting/cracking predicament the place aside lobsters are ready outdated to cooking. 

Also, 2 swabs accrued from the exterior surface of their cooling tank had been chanced on certain for Listeria monocytogenes on Aug. 3 and 25, 2021.

The company’s records indicated that they cleaned and sanitized every of those areas; on the opposite hand, the FDA notes that they didn’t behavior a root cause investigation on the time sample outcomes had been got to fetch out the source of the contamination. On Oct. 2, 2021, after the FDA presented their concerns with the certain Listeria monocytogenes findings, the company performed a voluntary rob of all frozen RTE lobster products that had been in contact with these Listeria monocytogenes certain surfaces. 

Seafood HACCP


One of the most most company’s main deviations are as follows:

  1. The company must contain a HACCP idea that, at a minimum, lists monitoring procedures and their frequency for every serious retain watch over point. On the other hand, the company’s HACCP idea for RTE vacuum-packed cooked lobster meat lists a monitoring direction of and frequency on the cooking serious retain watch over point that is never any longer ample to retain watch over the food security hazard of pathogenic bacteria survival through cooking.

Particularly, the company’s HACCP idea lists a monitoring direction of for checking the interior lobster temperature (redacted) in the end of production. (Redacted) interior product temperature (EPIPT) monitoring technique. FDA recommends that they believe EPIPT monitoring on the very least every 30 minutes, and each time any changes in product-heating serious elements happen. This lengthen in monitoring frequency (redacted) to every 30 minutes is to make certain that that the lobster meat exiting the continuous cooker achieves a minimum 6 log reduction of Listeria monocytogenes to retain watch over the hazard of pathogens surviving the cooking direction of of their RTE cooked lobster products.

  1. The company must video display sanitation prerequisites and practices in the end of processing with sufficient frequency to make certain that compliance with most modern devoted manufacturing put together requirements, that are acceptable to their plant and the food being processed and expose to 1 in every of the areas specified.
  2. The company didn’t video display the necessities and practices in the end of processing with sufficient frequency to make certain that that drip or condensate from fixtures, ducts and pipes does no longer contaminate food. Right here is expounded to the protection of food from adulteration with condensate. Particularly, FDA investigators noticed a buildup of condensate on the ceiling above exposed RTE cooked lobster meat in the processing room.
  3. The company didn’t video display the necessities and practices in the end of processing with sufficient frequency to make certain that that their plant’s plumbing modified into adequately maintained to produce ample ground drainage in all areas the place aside floor are discipline to flooding-form cleansing or the place aside common operations originate or discharge water or various liquid raze on the ground. Right here is expounded to the prevention of irascible-contamination from insanitary objects to food, food packaging discipline cloth, and various food-contact surfaces. Particularly, condensate from an evaporator take care of conclude-bucket modified into overflowing onto the cooler ground. This modified into a repeat teach from the outdated inspection, as condensate modified into beforehand noticed to empty straight onto the ground of the cooler, and the company’s corrective traipse modified into to space a bucket underneath to be emptied as needed.

The stout warning letter would possibly perhaps also moreover be viewed right here.

Rainfield Marketing Neighborhood Inc.


Vernon, CA

An import firm in California is on plot from the FDA for no longer having FSVPs for a lot of imported food products.

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

The inspection modified into initiated after Listeria monocytogenes modified into chanced on in a sample of enoki mushrooms from (redacted) in Korea, accrued by the California Department of Public Properly being (CDPH), and imported by the company. The FDA acknowledges that the company initiated a voluntary rob of their enoki mushrooms. On July 21, 2021, enoki mushrooms from (redacted) had been positioned on Import Alert # 99-21 Detention Without Physical Examination of Kind As a result of Contamination With Human Pathogens.

The FDA’s inspection revealed that the company modified into no longer in compliance with FSVP regulations and resulted in the issuance of an FDA Possess 483a.

One of the most most company’s main violations of the FSVP law are as follows:

The company didn’t invent, withhold, and apply an FSVP for any of the foods they import, alongside side the next foods:

  • Perilla leaves imported from their out of the country dealer (redacted) located in (redacted)
  • Strawberries imported from their out of the country dealer (redacted) located in (redacted)
  • Strawberries imported from their out of the country dealer (redacted) located in (redacted)
  • Strawberries imported from their out of the country dealer (redacted) located in (redacted)
  • Garlic bulb imported from their out of the country dealer (redacted) located in (redacted)
  • Grapes imported from their out of the country dealer (redacted) located in (redacted)
  • Cilantro imported from their out of the country dealer (redacted) located in (redacted)
  1. The company’s onsite audit of their out of the country suppliers didn’t embody the valuable verification activities. Particularly, their onsite audit didn’t contain in mind the applicable food security law and a overview of the out of the country dealer’s written food security idea, if any, and its implementation, for the hazard being managed. For his or her out of the country suppliers, (redacted) Korea for enoki mushroom, (redacted) Korea for king oyster mushroom, and (redacted) for spinach, their verification activities didn’t contain in mind applicable FDA food security regulations and information relevant to the out of the country dealer’s compliance with those regulations.

Enoki mushrooms, king oyster mushrooms, and spinach are “covered believe” as outlined in federal law and therefore must comply with FDA’s Requirements for Rising, Harvesting, Packing and Preserving of Kind for Human Consumption (Meals Security Modernization Act (FSMA) Kind Security Rule) law. No longer one in every of the records the company supplied demonstrate their out of the country suppliers considered this law or processes and procedures that provide on the very least the identical stage of public health protection as the applicable food security law.

  1. The company didn’t retain documentation of every sampling and checking out of a food, alongside side identification of the food tested (alongside side lot quantity, as acceptable), the quantity of samples tested, the take a look at(s) performed (alongside side the analytical plot(s) worn), the date(s) on which the take a look at(s) had been performed and the date of the file of the checking out, the outcomes of the checking out, any corrective actions taken in response to detection of hazards, information figuring out the laboratory conducting the checking out, and documentation that the checking out modified into performed by a licensed particular person. Particularly, the company didn’t retain documentation of the quantity of samples tested, of the take a look at(s) performed, and that the checking out modified into performed by a licensed particular person, in accordance with their written direction of per 1.506(b), titled “Vendor Verification Notion and Narrative” dated June 28, 2021. The company submitted certificates of laboratory checking out for enoki mushrooms dated March 31, 2021, for receipt no. (redacted) and certificates of laboratory checking out dated April 13, 2021, for receipt no. (redacted) as documentation of their verification activity for (redacted). On the other hand, those certificates of laboratory checking out didn’t establish the quantity of samples tested, the take a look at plot(s), or the qualification of the particular person that performed the checking out.

The stout warning letter would possibly perhaps also moreover be viewed right here.

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