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. The FDA frequently redacts parts of warning letters posted for public view.
Kemal Balikcilik Ihracat
Turkey
An import company in Turkey is on notice from the FDA for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a Jan. 12, 2022, warning letter the FDA described a Sept. 7-14, 2021, Foreign Remote Regulatory Assessment (FRRA) inspection of Kemal Balikcilik Ihracat’s seafood processing facility in Urla, Turkey.
The FDA’s inspection revealed that the firm had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. At the conclusion of the assessment, the FDA investigator discussed items of concern. To date, the firm has not responded to the discussion items identified during the inspection.
Some of the firm’s significant deviations are as follows:
The firm must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points. A critical control point is defined as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can, as a result, be prevented, eliminated, or reduced to acceptable levels.”
However, the firm’s HACCP plans for aquaculture seabass, seabream, salmon, trout, and anchovy products, do not list the critical control point of receiving to control the food safety hazard of aquaculture drugs. Their HACCP plans identified the food safety hazard, but they did not consider the hazard critical or include adequate controls. FDA recommends they include a critical control point of receiving and include the critical limits.
In addition, the firm’s HACCP plans for tuna and anchovy products do not list critical control points of receiving, processing and refrigerated storage to control the food safety hazard of scombrotoxin (histamine) formation. Their HACCP plans identified the food safety hazard but did not consider the hazard critical or include adequate controls. For example, their current “(redacted)” processing step lists a processing limit of “(redacted)” that does not ensure that the presence of histamine is no more than (redacted) ppm in the edible portion of the fish for each lot of scombrotoxin-forming fish received.
The full warning letter can be viewed here.
Sergio Carranza dba MR CHESCOS
Houston, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Feb. 3, 2022, warning letter the FDA described a June 28 to Aug. 25, 2021, Foreign Supplier Verification Program (FSVP) inspection of Sergio Carranza dba MR CHESCOS in Houston, TX.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Cola flavored carbonated soft drinks imported from foreign supplier (redacted)
- Grape flavored carbonated soft drinks imported from foreign supplier (redacted)
- Banana flavored carbonated soft drinks imported from foreign supplier (redacted)
The full warning letter can be viewed here.
All Good Foods Inc.
City of Industry, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Feb. 7, 2022, warning letter the FDA described a Dec. 1-2, 2021, Foreign Supplier Verification Program (FSVP) inspection of All Good Foods Inc. in City of Industry, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Frozen Tiny Red Chili imported from their foreign supplier, (redacted) in (redacted)
- Frozen Chopped Lemon Grass imported from their foreign supplier, (redacted) in (redacted)
The full warning letter can be viewed here.
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