Bakery Warning Letter
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
Category: FDA Warning Letters
Seafood Processor Receives Warning Letter
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
Fishery Warned of DWPE
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
Bakery Cited for FSP Inadequacies
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
Sprout Operation Receives Warning Letter
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
Baking Company Receives Warning Letter
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
Facility Cited for Lack of Hazard Analysis and Misbranding
Following an inspection of a sprouting and noodle facility in early 2024, a 483 was issued. After FDA reviewed the firm’s response, a warning letter
Papaya Farm Receives Warning Letter
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
Listeria Prompts Warning Letter
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
Inadequate Seafood HACCP
A seafood processor was cited for violations of the seafood HACCP regulations. Specific findings include: HACCP plans must be rooted in science and include controls
