Gilead Sciences Lands Form 483 Due to Production Issues

July 10, 2015

The FDA handed Gilead Sciences an eight-observation Form 483 for an array of production issues, including poor manufacturing instructions and processing procedures.

The 483 — issued following a May 7 to 16, 2014, inspection of the company’s San Dimas, Calif., facility — faults the firm’s master production and control records for failing to provide complete manufacturing and control instructions and special notations for operators. Reprocessing procedures also lack steps to ensure that reprocessed batches conform to established standards, specifications and characteristics.

Moreover, Gilead’s production and control records lack a statement of theoretical yield, and there the company failed to thoroughly review unexplained inconsistencies and batch failures, the form says.

During the inspection, the investigator observed that quality control unit procedures and responsibilities aren’t fully followed and deviations from written standards and laboratory procedures aren’t justified.

Further, there is no assurance that the air supply in sterile processing areas is filtered through high-efficiency particulate air filters. The company does not provide adequate written instructions to demonstrate the filtered unidirectional downward air coverage at the conveyor table area, the 483 said.

Finally, unlabeled drug product that was set aside to be further inspected by the facility was never inspected and was later incorrectly identified as ready to be labeled and packed, the form says.

Gilead Sciences did not return a request for comment by press time.

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