GMP News - Inspections/Audits

In a blog post, the UK MHRA comments on the resumption of international GMP inspections and the validity of expired GMP certificates.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. Therein, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, a manufacturer of OTC drug products had been found to have significant deficiencies in these areas.

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

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.

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.

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.

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.