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The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a OTC drug manufacturer in Mexico. No procedure to handle OOS results was in place, and drug product with OOS results were released and distributed. There was also a lack of stability data and the quality unit did not provide adequate oversight.

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In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.

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The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an Indian company, registered as a manufacturer of OTC and homeopathic drug products. Some of the formulations contain high percentages of glycerin, but this high-risk component was not adequately tested according to the USP requirements. Thus, it was not ensured that the relevant safety limits for the levels of diethylene glycol or ethylene glycol were met.

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The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturer in California. The FDA blames the company of various CGMP violations, particularly in the areas of release testing, sampling, stability testing and process validation.

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In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.

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The U.S. Food and Drug Administration (FDA) has published a new guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act". The document clarifies the agency's interpretation of specific terms used in the definitions of "suspect product" and "illegitimate product". It is primarily intended to assist trading partners in meeting verification obligations.

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The U.S. Food and Drug Administration (FDA) has published a Warning Letter sent to a drug manufacturer in Massachusetts, USA. Since the deficiencies found even concern simple GMP basic requirements, the company had to stop production and distribution in the meantime. What is actually interesting is that the FDA, among other things, explicitly criticizes the lack of a humidity control in the warehouse.

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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two guidance documents for GDP inspectors, an Aide-Memoire on GDP inspections and a Q&A document. Both documents entered into force on 01 February 2023.

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Due to numerous and fundamental GMP deficiencies, the FDA has issued a Warning Letter to a manufacturer of over-the-counter antibacterial hand soap, antiseptics and hand sanitizer in Puerto Rico.

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The U.S. Food and Drug Administration (FDA) has once again published a Warning Letter to a US manufacturer of hand sanitizers. During an inspection, several CGMP violations were found. In addition to inadequate release testing in general, the finished products are likely to be contaminated with methanol.

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