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...

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...

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:

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 incomplete hazard analysis, GMP concerns, and lack of allergen controls: While it can be easy...

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 prevent their contamination with potential hazards; cleaning and sanitizing procedures for equipment not recorded as...

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 environment, including from food contact surfaces, a sprouting operation initiated a swabbing plan. However, 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 FDA findings and cause for a warning letter to a noodle company in Colorado. The...