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
Category: FDA Warning Letters
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
Environmental Issues
Due to both sanitation and environmental pathogenic contamination concerns, a manufacturer of RTE soft tortillas received an FDA warning letter citing sanitation SOP deviations, including
Warning letter includes lack of mycotoxin hazard analysis
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
Soy Protein
After an inspection of an RTE soy protein isolate manufacturing facility, FDA issued a 483, then a warning letter due to observations and continuing concerns
Acidic Foods Manufacturer Warned for Noncompliance
A manufacturer of acidified foods was found to be in violation of the Acidified Foods regulations because they did not fully comply with registration and
