After the FDA inspected an RTE dairy facility, they issued a 483; although the dairy responded to the 483, the FDA then issued a Warning Letter, advising the dairy of its continuing concerns, including:

During an inspection of a papaya farm, investigators noted a number of observations in violation of the Produce Safety Rule. The violations included papayas not stored properly to prevent their contamination with potential hazards, the lack of toilet facilities for...

Following an FDA inspection in Fall of 2023 of a bakery facility that manufactures RTE items, a 483 was issued, but never responded to, so a warning letter was issued.  The findings included:

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 the farm’s lack of response to the FDA 4056 identifying violations observed during a January...

With Listeria monocytogenes having been detected in product samples at a family sprout facility by the state department of agriculture in September 2024, and a recall initiated, the FDA inspected the facility in October. Noting violations of the Produce Safety...

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 issued the bakery a warning letter with most of the observed findings being repeats from...

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 analysis did not identify scombrotoxin (histamine) formation as a potential hazard and that critical limits...

During an inspection of a Portuguese seafood processor in Portugal, the FDA identified serious HACCP Violations for which it issued a 483. Among the violations were: Although the processor responded to FDA with revisions to its HACCP plans for canned...

In a warning letter following the lack of satisfactory response to an inspection’s 483, a Michigan bakery that makes RTE foods was cited for concerns related to their Food Safety Plan including:

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 areas and issued a Warning Letter with the following findings: