The FDA said the four-day inspection last month found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
It added that further action, such as seizing products or stopping the company from operating, could be taken if the violations are not corrected.
The agency said the failure of a processor of fish or fishery products to have and implement a HACCP plan that complies or otherwise operate in accordance with the relevant requirements renders the fish or fishery products adulterated.
“Accordingly, your ready-to-eat (RTE), seafood products, including refrigerated ready to eat (RTE) crabmeat are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”
The FDA acknowledged receipt of an email dated 8 February but called the response “unacceptable” because it did not “provide any documentation that these deficiencies have been corrected and there is no assurance that your proposed corrections will prevent re-occurrence.”
Violations in the letter, dated 13 February to the owner/manager Adelbert F. Gross, included the cooking critical limit in the HACCP plan relevant to crabmeat.
The FDA said the cooking critical limits for RTE crabmeat should be validated to ensure that the food safety hazard of pathogenic bacteria is controlled during the cooking step.
The agency acknowledged the response from the firm promising a validation study and said documentation is needed to show the study has been completed and the HACCP plan revised.
An inspection found the record keeping system in the HACCP plan for crabmeat was not complete for at least three days (12 August and 10 November 2012 and 12 January 2013).
Another violation was related to monitoring procedures and the frequency for each critical control point.
“Your firm’s HACCP plan for crabmeat lists a monitoring procedure at the storage critical control point that is not adequate to control pathogen growth,” said the FDA in the letter.
It adds that the plan lists a visual check of the ambient air temperature which is not adequate to ensure that crabmeat is held at a safe temperature throughout storage.
“We note that you have a continuous temperature monitoring device for your cooler, however you are not checking or reviewing these monitoring records to ensure that your critical limit is not exceeded.”
According to Stonington Sea Products website their HACCP certified facility’s focus is on quality not quantity and is described as “modest” compared with other seafood processing plants
The firm added that no high tech machines are used in the production of seafood with products picked or shucked by hand.