Biocon Biologics' Insulin Facility Gets Eight Observations Post US FDA Inspections

The US Food and Drug Administration conducted a Current Good Manufacturing Practice inspection at Biocon Biologics' insulin manufacturing facility in Malaysia from Sept. 17 to Sept. 27. The inspection covered multiple units within the facility, including drug substance and drug product manufacturing, medical device assembly, analytical and microbiological quality control laboratories, and warehouse operations.

At the conclusion of the inspection, the FDA issued a Form 483, outlining eight observations across the facility's units. The drug substance and drug product facilities received five observations, while the analytical and microbiological quality control laboratories received three.

The medical device assembly unit and warehouse operations had zero observations, indicating compliance in those areas.

The eight key observations from the FDA inspection were:

Lack of written procedures for microbiological contamination control: There were no established or written procedures designed to prevent microbiological contamination in sterile drug products.

Inadequate validation of contamination prevention procedures: The facility's procedures for preventing contamination were found to lack proper validation, raising concerns about their effectiveness.

Quality control lapses: The responsibilities and procedures applicable to the quality control unit were not properly documented or fully followed.

Failure to review discrepancies: The facility did not review unexplained discrepancies, even in cases where batches had already been distributed.

Deficiencies in aseptic processing areas: The system for cleaning and disinfecting aseptic processing areas was found inadequate to maintain sterile conditions.

Inadequate production controls: The facility failed to establish written procedures for production and process controls to ensure that the drug products met the required identity, strength, purity, and quality standards.

Incomplete batch records: The batch production and control records lacked documentation of critical steps in manufacturing, processing, and packing.

Weak computer system controls: Appropriate controls over computer systems were not in place, allowing for unauthorised changes to master production and control records.

Despite these observations, the FDA noted that there were no issues related to data integrity, systemic deficiencies, or quality oversight during the inspection.