FDA Warning Letters
PSR Violations Trigger Warning Letter
FDA has issued a warning letter to a farm in Hawaii that grows and packages hearts of palm. The warning letter was a result of
TAG
July 15, 2025
FDA has issued a warning letter to a farm in Hawaii that grows and packages hearts of palm. The warning letter was a result of
Citing serious violations related to GMPs, hazard analysis, and preventive controls, FDA issued a 483 to a bakery. Having received no written response, the agency
During an FDA inspection at a Vietnamese seafood processor, investigators observed noncompliances with the processor’s HACCP program. Among the serious concerns were that the hazard
Although a sprouting operation responded to the citations of the FDA 483 it received following an inspection, the FDA remained concerned about a number of
Following the issuance of a 483 to a baking company, to which it did not respond, FDA issued a warning letter focused on the company’s
A papaya farm was cited for violations of the Produce Safety Rule including a lack of toilet facilities for employees; papayas not stored properly to
Having been cited in a 483 for the lack of written plan for environmental monitoring for Listeria and FDA swabs revealing Listeria monocytogenes in the
The lack of identification and evaluation of mycotoxins as a potential hazard and incomplete implementation of supply chain controls comprised just one area of the
Since the beginning of 2023, FDA has issued nearly 40 warning letters with citations for lack of or inadequate HACCP implementation. This doesn’t even begin
In a 2023 inspection, FDA determined that the soybean sprouts grown in a sprout and kimchi operation were adulterated as they were prepared, packed, or
