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After incomplete processing of defects listed in a 483, the Austin-based compounding manufacturer Texas Longhorn received a Warning Letter from the FDA.

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In April, the US FDA inspected a manufacturer of OTC products in Mexico. Due to the deficiencies found, in particular the unacceptable risk of contamination, the production was stopped.

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The US Food and Drug Administration (FDA) has updated two Compliance Program Guides (CPGs) on GMP inspections. One for pre-approval inspections (PAI) and one for routine surveillance inspections.

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FDA's Office of Regulatory Affairs (ORA) publishes electronic copies of various inspection and related records on their websites.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.

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GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?

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The U.S. Food and Drug Administration (FDA) has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.

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When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for air freight operations.

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The FDA has published a report on the state of drug quality - and the results are mixed. However, if one takes a closer look, the reasons can be quickly identified.

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In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company "Jost Chemical Co." after having inspected its site in January 2022. The Warning Letter mentions the list of cGMP observations for Active Pharmaceutical Ingredients (APIs).

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