FDA increases Number of unannounced Inspections

Recommendation

12-14 September 2023

Granulation & Tableting - Live Online Training
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms

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.