FDA Slams Cadila for Cross-Contamination, Aseptic Practices
Indian drugmaker Cadila Healthcare was slapped with an FDA warning letter for serious violations at its injectable drug manufacturing facility in Ahmedabad, including cross-contamination from non-dedicated equipment.
Agency investigators logged four serious violations during an inspection of the facility, including an inadequate cleaning procedure for non-dedicated equipment. The agency flagged similar CGMP violations in previous warning letters issued to the facility in 2011 and 2015.
“Significant equipment flaws and cleaning deficiencies resulted in cross-contamination between your drug products,” the FDA said. For example, multiple pieces of equipment used in production were marked as clean but contained contamination from what appeared to be different products, the agency said.