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Due to deficiencies found in an FDA inspection, a US pharmaceutical manufacturer has now received a Warning Letter. Among other things, a dead leg in the pharmaceutical water system is listed as a deficiency.

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The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. An OTC manufacturer received information indicating that the finished drug products produced with isobutane propellants were contaminated with benzene. The company's own analyses as well as results of the FDA laboratory testing confirmed the presence of this impurity. The company failed to perform adequate investigations and so far, the root cause of the benzene contamination is not understood.

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In March 2023, the EDQM once more prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" and has now published it in the newsroom of the EDQM website.

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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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