Deficiencies Continue to Plague Dr. Reddy’s Facility
The FDA has cited a Dr. Reddy’s manufacturing site for a slew of violations, including deficient air supply in aseptic processing areas and a lack of microbiological testing.
Agency investigators issued a Form 483 with eight observations following an Aug. 12-20 inspection of the Indian drug giant’s Duvvada, Andhra Pradesh facility.
The facility failed to conduct microbiological tests on components, drug product containers and closures, the investigators found. The firm failed to include all microorganisms from a test plate during a routine colony forming unit microbial count, the agency said.