FDA 483 - Sun Pharmaceutical Industries Ltd. - May 09, 2022

This FDA Form 483 document outlines multiple deficiencies observed during an inspection. The facility's procedures for preventing microbiological contamination of sterile drug products lacked adequate aseptic process validation. The system for monitoring environmental conditions in aseptic processing areas was found deficient. Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination. Furthermore, equipment design was not appropriate to facilitate intended use, cleaning, and maintenance.

Deficiencies were also noted in separate or defined areas for aseptic processing, which failed to prevent contamination or mix-ups. The written stability testing program was not followed. Laboratory controls lacked scientifically sound and appropriate sampling plans to assure drug product conformity. The responsibilities and procedures of the quality control unit were not fully followed. There was a failure to thoroughly review unexplained discrepancies and batch failures to meet specifications. Finally, employees engaged in manufacturing and processing lacked the required training for their assigned functions.