Eugia Inspection Results in 7-Item FDA 483

A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.’s Telangana, India sterile drug manufacturing facility has resulted in a seven-item Form FDA 483 that cites significant GMP deficiencies.

According to the just-posted inspection report, the Eugia facility did not follow procedures that are designed to prevent microbiological contamination of drug products. The agency investigators also found that written records are not always made of investigations into unexplained discrepancies. And it says that equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use, among other issues.

The inspection report comes on the heels of FDA 483 issued in January following a 1/22-2/2 inspection at Eugia Pharma Specialties in Sangareddy, Telangana, India. That inspection resulted in a 26-page, nine-inspection observation report (see earlier story).