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Category: FDA Warning Letters

Seafood Processor Receives Warning Letter

Cat Links FDA Warning Letters Posted on April 29, 2025April 29, 2025 TAG

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 hazardContinue readingSeafood Processor Receives Warning Letter

Fishery Warned of DWPE

Cat Links FDA Warning Letters Posted on March 31, 2025March 31, 2025 TAG

During an inspection of a Portuguese seafood processor in Portugal, the FDA identified serious HACCP Violations for which it issued a 483. Among the violationsContinue readingFishery Warned of DWPE

Bakery Cited for FSP Inadequacies

Cat Links FDA Warning Letters Posted on March 17, 2025March 17, 2025 TAG

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 concernsContinue readingBakery Cited for FSP Inadequacies

Sprout Operation Receives Warning Letter

Cat Links FDA Warning Letters Posted on February 18, 2025February 18, 2025 TAG

Although a sprouting operation responded to the citations of the FDA 483 it received following an inspection, the FDA remained concerned about a number ofContinue readingSprout Operation Receives Warning Letter

Baking Company Receives Warning Letter

Cat Links FDA Warning Letters Posted on February 10, 2025February 10, 2025 TAG

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’sContinue readingBaking Company Receives Warning Letter

Facility Cited for Lack of Hazard Analysis and Misbranding

Cat Links FDA Warning Letters Posted on January 28, 2025January 28, 2025 TAG

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 letterContinue readingFacility Cited for Lack of Hazard Analysis and Misbranding

Papaya Farm Receives Warning Letter

Cat Links FDA Warning Letters Posted on January 14, 2025January 14, 2025 TAG

A papaya farm was cited for violations of the Produce Safety Rule including a lack of toilet facilities for employees; papayas not stored properly toContinue readingPapaya Farm Receives Warning Letter

Listeria Prompts Warning Letter

Cat Links FDA Warning Letters Posted on December 30, 2024December 30, 2024 TAG

Having been cited in a 483 for the lack of written plan for environmental monitoring for Listeria and FDA swabs revealing Listeria monocytogenes in theContinue readingListeria Prompts Warning Letter

Inadequate Seafood HACCP

Cat Links FDA Warning Letters Posted on December 10, 2024December 10, 2024 TAG

A seafood processor was cited for violations of the seafood HACCP regulations. Specific findings include: HACCP plans must be rooted in science and include controlsContinue readingInadequate Seafood HACCP

Environmental Issues

Cat Links FDA Warning Letters Posted on October 29, 2024October 29, 2024 TAG

Due to both sanitation and environmental pathogenic contamination concerns, a manufacturer of RTE soft tortillas received an FDA warning letter citing sanitation SOP deviations, includingContinue readingEnvironmental Issues

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Continued H5N1 Spread Calls for Sustained Vigilance

May 21, 2025

California Food Date Labeling Law to Impact Entire Food Industry

May 19, 2025

Canadian Food Facilities Fate Furthered for Unannounced FDA Inspections

May 15, 2025

What to Make of the HHS Requirement for Placebo Testing of Vaccines

May 13, 2025

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