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A Chinese company was placed on import alert by FDA because investigators observed significant deviations from cGMP. In some cases, the company told the untruth.

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Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections, as a recent FDA Warning Letter shows.

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The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.

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A pharmaceutical manufacturer in India received a Warning Letter from the US-American FDA in December due to deficiencies in the areas of maintenance/cleanliness, OOS and data integrity. Read more here.

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A US-American pharmaceutical manufacturer received a Warning Letter from the FDA in November 2019 due to microbial issues in the water system, deficiencies in qualification/validation and insufficient stability data. Read more here.

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Stability testing of drug products is required by 21 CFR 211.166 of the cGMP guidelines. There has been an increase in GMP violations related to stability testing. A few days ago, a German company received an FDA Warning Letter in which, among others, the stability program was criticized.

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The US Food & Drug Administration (FDA) recently sent a Warning Letter to a US pharmaceutical company criticising batch record design and review and quality oversight.

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The first FDA warning letter of the year goes to a Chinese contract manufacturer of over-the-counter (OTC) drug products for multiple violations of current good manufacturing practice (cGMP).

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Four of five Warning Letters recently published broached the issue of handling deviations and inadequate CAPA.

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EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use.

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