FDA sends warning letters to companies in the Netherlands and Thailand

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.

Neptunus Seafood B. V. — Enschede Netherlands

The Food and Drug Administration sent a warning letter dated Jan. 22, 2020, to the Director of Neptunus Seafood B. V., Martin Haasnoot.

During an inspection at Neptunus Seafood B. V. ‘s seafood processing facility on Oct. 22-23, 2019, FDA investigators found serious violations of the seafood Hazard Analysis and Critical Point (HACCP).

In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility.

FDA received a response by mail on Nov. 5 and 11, 2019. The FDA’s warning letter explains how the response was not adequate.

The violations noted by the FDA:

A HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR. A critical limit is defined in as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, Neptunus Seafood B. V. firm’s HACCP plan, dated November 11, 2019, for refrigerated pickled herring products, list critical limits that are not adequate to control the identified food safety hazards.
The critical limits of “(redacted),” “(redacted)” critical control point to control scombrotoxin (histamine) formation and pathogen growth and toxin formation are not adequate. FDA recommends:
To control scombrotoxin (histamine) formation during processing (e.g., thawing, brining, curing, packaging, and labeling) of scombrotoxin-forming fish or fishery products that have been previously frozen such as the frozen herring fillets Neptunus Seafood B. V. processes into various pickled herring products:

The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);

The fish are not exposed to ambient temperatures above 40°F (4.4°() for more than 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).

To control pathogen growth and toxin formation during unrefrigerated processing of raw, ready-to-eat products:

“If at any time the product is held at internal temperatures above 70°F (21.1°C), exposure time (i.e., time at internal temperatures above 50°F (10°C) but below 135°F (57.2°C)) should be limited to 2 hours (3 hours if S. aureus is the only pathogen of concern);”
“Alternatively, exposure time (i.e., time at internal temperatures above 50°F (10°C) but below 135°F (57.2°C)) should be limited to 4 hours, as long as no more than 2 of those hours are between 70°F (21.l°C) and 135°F (57.2°C);”
“If at any time the product is held at internal temperatures above 50°F (10°() but never above 70°F (21.1 °C), exposure time at internal temperatures above 50°F (10°C) should be limited to 5 hours (12 hours if S. aureus is the only pathogen of concern);”
“The product is held at internal temperatures below 50°F (10°C) throughout processing;”

“Alternatively, the product is held at ambient air temperatures below 50°F (10°C) throughout processing.”

Neptunus Seafood B. V. critical limit of “(redacted)” is not adequate to control Clostridium botulinum (C. botulinum) toxin formation. FDA does not recommend that processors rely on monthly finished product testing to control C. botulinum toxin formation. FDA recommends processing controls such as the following:
To control C. botulinum toxin formation during thawing of vacuum packaged fish, the product be thawed at a cooler temperature of 38°F (3 .3°C) or below, immediately before use.
To control C. botulinum toxin formation in refrigerated reduced oxygen packaged finished product, the minimum or maximum values for the critical factors of the brining, pickling, or formulation process should be established by a scientific study. The critical factors are those that are necessary to ensure that the finished product has:

“A water phase salt level of at least 5%.”
“A pH of 5.0 or below.”
“A water activity of below 0.97.”
“A combination of water phase salt, pH, and/or water activity that, when combined, have been demonstrated to prevent the growth of C. botulinum type E and non-proteolytic types B and F.”

Neptunus Seafood B. V. must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, the firm’s HACCP plan, dated November 11, 2019, for refrigerated pickled herring products, lists a monitoring procedure at the “(redacted)” critical control points that is not adequate to control C. botulinum toxin formation and scombrotoxin (histamine) formation. Specifically, the monitoring procedures of “(redacted)” and “(redacted)” is inadequate. FDA recommends that firms monitor the temperature of the cooler using a continuous temperature-recording device (e.g., a recording thermometer) and a visual check of the recorded data at least once per day.
Because Neptunus Seafood B. V. chose to include a corrective action plan in their HACCP plan, the described corrective action must be appropriate, to comply with 21 CFR. However, the corrective action plans for the refrigerated pickled herring products at the “(redacted)” critical control points to Neptunus Seafood B. V. corrective action plans, when a deviation from the critical limit occurs, they will “(redacted).” However, it is not clear from this description if the firm will ensure that violative product will not enter into commerce. In addition, the corrective action must ensure the cause of the deviation is corrected.

A complete list of the violations can be found in the FDA’s warning letter.

Food Canning Ltd., Part., — Chiang Mai, Thailand

The Food and Drug Administration sent a warning letter dated Jan. 22, 2020, to the Owner of TP. Food Canning Ltd., Part., Paisit Jittasirinuwat.

During an inspection at TP. Food Canning Ltd., Part.‘s low-acid canned food (LACF) product facility FDA investigators found serious violations of the Emergency Permit Control regulation.

In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility.

The violations noted by the FDA:

“You must file the scheduled processes with the FDA for each low-acid food in each container size as required by 21 CFR 108.35(c)(2). This filing must occur not later than 60 days after registration and prior to the packing of a new product and include the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each product in each container size. Specifically, as noted during the inspection, your firm failed to file a scheduled process with FDA for your bamboo shoots in water packaged in cans and processed in (redacted). However, to date our office has not received your process filings for the bamboo shoots you manufacture and ship to the United States.”

“Your firm did not provide evidence that the scheduled processes for the low-acid and acidified food products that you manufacture were established by a qualified person who has expert knowledge acquired through appropriate training and experience in thermal processing requirements for low-acid foods in hermetically sealed containers as required by 21 CFR 113.83. We noted during the inspection that your firm has not established the critical parameters such as minimum time and temperature for processing bamboo shoot tips in water packaged in (redacted) oz. cans in (redacted). It appears the parameters used for processing the product in (redacted). You promised to consult your process authority to validate the process in (redacted) at the conclusion of the inspection. However, evidence of validation records such as temperature distribution or heat penetration data supporting the processing of bamboo shoots in (redacted) has not been provided. We recommend that your firm work with a competent authority to develop and file the necessary scheduled processes for your low acid food operation.”

A complete list of the violations can be found in the FDA’s warning letter.