USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant

US health regulator issues warning letter to Intas Pharmaceuticals CEO and MD Nimish Chudgar for manufacturing lapses and violation of CGMP regulations at the Matoda-Sanand facility in Ahmedabad. The USFDA found various manufacturing lapses and inadequate oversight in the company's Quality Assurance and production departments. Specifically, the investigation revealed manipulation of defect counts on visual inspection records to avoid rejection limits. The company also failed to thoroughly investigate discrepancies and establish written procedures for production controls and prevention of microbiological contamination.