Loading…
Chemspec Chemicals Private Limited, an active pharmaceutical ingredient (API) manufacturer in India, was found to be producing adulterated drugs due to significant Current Good Manufacturing Practice (CGMP) deviations during an FDA inspection in July 2025. The company's quality unit failed to exercise adequate oversight and control, including inadequate document control of batch production records, failure to maintain complete manufacturing records for multiple API lots prior to distribution, and insufficient enforcement of data integrity principles among employees. The facility manufactured and released API lots without proper batch records and did not identify these critical deficiencies until cited by FDA investigators during the inspection.