FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - February 21, 2020

An FDA inspection identified significant Good Manufacturing Practice (GMP) deficiencies at a pharmaceutical company, primarily concerning sterile manufacturing operations. The inspection, which reviewed activities around January-February 2020 and earlier, revealed three main observations.

Firstly, the company failed to thoroughly investigate unexplained discrepancies in batch records, specifically regarding environmental monitoring interventions in the Grade A aseptic filling unit. Undocumented interventions and unexplained durations were noted as far back as February 2019, without proper assessment of potential product quality impact.

Secondly, procedures designed to prevent microbiological contamination were not adequately established or followed. The airflow visualization requalification for the Grade A filling unit, approved in February 2020, did not accurately reflect filling processes or critical unidirectional airflow during interventions like component replenishment. Video evidence did not demonstrate compliance with acceptance criteria.

Lastly, the quality control unit exhibited deficiencies in its responsibilities and adherence to procedures. An operational qualification for a critical integrity tester within the Grade A filling unit was missing. Furthermore, a corrective action preventative action (CAPA) related to out-of-trend product quality results (April 2018-March 2019) was prematurely closed in November 2019 without completing necessary investigations, corrective actions, or effectiveness checks. The firm is required to address these issues to ensure product safety and quality, aligning with regulatory expectations for sterile drug manufacturing.