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.
David Rosen Bakery Supplies Inc. dba David Rosen Company, Maspeth, NY
Jeremy Rosen, president
In an Apr. 1, 2020, warning letter the FDA described a Feb. 5 inspection at David Rosen Bakery Supplies Inc.. Inspectors found that the company was not in compliance with Foreign Supplier Verification Program (FSVP) regulation. FDA’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations.
FDA inspection revealed the following violations:
The company did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for each of the following foods manufactured by Grupo La Florida Mexico S.A. de C.V., Tlalnepantla de Baz, Tlalnepantla, Mexico:
- Strawberry filling diamante,
- Pineapple filling diamante, and
- Multicolor sprinkles diamante
The full warning letter can be viewed here.
Macduff Shellfish – Scotland – Ltd, Mintlaw, UK
Roy Cunningham, CEO, COO, VP
In a Apr. 3, 2020, warning letter the FDA described a Dec. 5-7, 2019, inspection at Macduff Shellfish (Scotland), Ltd, Phoenix, AZ. Inspectors found that the company has serious violations of the federal seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
The FDA acknowledged receipt of their response to the FDA-483 on Feb. 3, which included corrective actions taken and planned. However, the FDA’s evaluation of the response revealed it was not adequate. After reviewing the responses that the firm provided, the FDA is issued the warning letter to advise the company of the agency’s concerns and provide detailed information describing the findings at their facility.
The FDA inspection revealed the following violations:
- The firm must conduct or have conducted a hazard analysis for each kind of fish and fishery product that they produce 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 food safety hazards that are reasonably likely to occur.
- The firm’s HACCP plan, entitled “Whole Brown Crab – Cooked Frozen” for their RTE frozen cooked (redacted)‐packed whole rock crab products, does not list the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation. The firm distributes RTE frozen cooked rock crab products in (redacted)‐packaging. This type of packaging creates an environment which is conducive to C. botulinum growth and toxin formation. FDA recommends that their HACCP plan include appropriate controls to ensure each product is appropriately labeled with handling instructions.
- The firm’s HACCP plan, entitled “Whole Langoustine” for their ready‐to‐cook whole frozen lobster products, does not list the food safety hazard of undeclared major food allergens and food intolerance substances. The firm receives whole raw lobsters that are treated on the (redacted). It was observed that their lobsters are also dipped in (redacted)% (redacted) solution by your firm. FDA recommends that their HACCP plan include appropriate controls to ensure all allergens and food intolerance substances are declared on the labels.
- The firm must take an appropriate corrective action when a deviation from a critical limit occurs. However, the firm did not take a corrective action to control pathogenic bacteria survival when your process for “Whole Brown Crab – Cooked Frozen” deviated from their critical limit at the ”(redacted)” critical control point. Specifically, the firm’s HACCP plan includes a critical limit of “(redacted)”. However, their production records indicate that on one occasion the data logger, placed inside a crab and passed through the continuous cooker unit, reached an internal temperature of (redacted)°C for only (redacted) seconds. There were no documented corrective actions and this batch was subsequently exported to the U.S.
The firm’s response indicates that they have drafted a new monitoring document to record “(redacted)” that may occur during the crab cooking process. However, it is not clear from their response how they will use this record to evaluate whether the product received an adequate cook and how they will ensure the corrective action will be documented.
- Because they chose to include a corrective action plan in their HACCP plan, the described corrective actions must be appropriate. However, the firm’s corrective action plan for “Whole Brown Crab – Cooked Frozen” at the “(redacted)” and “(redacted)” critical control points is not appropriate. Their corrective actions do not ensure that adulterated products do not enter commerce.
Their response included revised corrective actions that continue to be inadequate. Their corrective actions at the “(redacted)” and “(redacted)” critical control points rely on microbiological testing of affected product. However, the reliance on microbiological testing is not appropriate as a corrective action when a (redacted) or (redacted) critical limit is not met. FDA recommends that processors reject the lot or re‐cook when a (redacted) or (redacted) critical limit has not been met.
The full warning letter can be viewed here.
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