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The FDA has recently issued a Warning Letter to a large Indian pharmaceutical manufacturer following an inspection that revealed poor cleaning and later detected cross-contamination in manufactured tablets. Further GMP violations were detected like leaking HEPA filters and inadequate smoke studies in the sterile area.

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EMA, EC and HMA have created a Q&A document on regulatory expectations during the covid-19 pandemic. New questions and answers are dealing with remote audits and remote release.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Romania-based manufacturer of an unapproved new drug due to, among others, releasing drug products without conducting identity and strength testing.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.

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A Chinese manufacturer has received a Warning Letter from the US-American FDA due to inadequate equipment design, deficiencies in monitoring and not performed laboratory tests as well as deficiencies in the Batch Record Review.

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A US-American pharmaceutical manufacturer of OTC solutions and suppositories has received a Warning Letter from the US-American FDA due to non-executed repairs and deficiencies in cleaning and laboratory testing.

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Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?

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FDA Warning letters often refer to insufficient documentation, missing validations, inadequate training, employees not following procedures, or similar cases. But shredding documents and leading investigators to incorrect rooms during an inspection is rather unusual.

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EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts.

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In response to the COVID-19 outbreak, FDA has decided to postpone most foreign inspections until the end of April.

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