Intas Pharmaceuticals under FDA scrutiny after oversight in GMP documents
pharmafile | January 20, 2023 | News story | Manufacturing and Production |
India-based manufacturer Intas Pharmaceuticals has been issued a Form 483 by the FDA after three investigators found a “cascade of failure” in a site inspection carried out at their manufacturing facility in Pharmez Special Economic Zone (SEZ) between late November and early December 2022.
Form 483 is issued by investigators when they observe “objectionable” conditions. In Intas Pharmaceuticals’ case, inspectors found an unignorable amount of issues, including incomplete lab records and a “cascade of failure” in the quality unit’s oversight of Good Manufacturing Practices (GMP) documents.
On 22 November, investigators allegedly found shredded documents in rubbish bins, a truck and hidden under a staircase, in bags which, when opened, spread “a very strong smell of chemical … across the area.”. This led to investigators accusing quality control (QC), production and engineering department employees of destroying GMP documents “pertaining to original records and raw data.”
More issues were discovered, such as “procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed, and the failure “to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity and quality that they are purported or represented to possess.”
Intas Pharmaceuticals is part of the 24-member Indian Pharmaceutical Alliance (IPA), and exports its products to the US, EU and emerging markets. It makes solid and liquid oral products and injectables at the Pharmez site.