FDA increases Number of unannounced Inspections

Recommendation

9-11 April 2024

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Good Engineering Practice for Pharmaceutical Companies and Suppliers

The FDA increases the number of unannounced inspections abroad. So far, only companies located in the US have been concerned by unannounced inspections. This way, the FDA responds to the growing number of GMP deviations in Indian pharmaceutical companies, where inspections had always been performed with prior notice. India is the second largest supplier of generics for the American market. The FDA aims to prevent from a potential falsification of GMP relevant documents. For example, unannounced inspections have already been performed at Sun Pharmaceuticals in Halol and at Dr Reddy's in Visakhapatnam. One can thus expect that this procedure will be continued. So far, unannounced inspections of the FDA in Europe are not known.