International Drugmakers Earn Warning Letters Over Quality Controls
The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls.
Intega Skin Sciences, based in Quebec, Canada, was cited for not conducing validation studies to demonstrate its cleaning procedures for non-dedicated production equipment were adequate to prevent contamination.
Additionally, the firm did not investigate the out-of-specification results of 11,000 colony forming units of its drug product, which were released for distribution.
FDA investigators also discovered that Intega failed to establish adequate written procedures to ensure it receives drug product complaints and investigates them thoroughly. Furthermore, it failed to ensure its manufactured products have the appropriate identity, strength, quality and purity.
Separately, the FDA inspected Antibioticos do Brasil in April, finding that the firm’s sterile filling line lacked unidirectional airflow in the ISO 5 aseptic filling zone. As a result, airflow in the filling zone is not sufficiently robust to protect its sterile injectables against contamination.
The Sao Paulo plant failed to adequately document environmental monitoring, the warning letter said. The FDA collected environmental monitoring samples from all locations designated in the firm’s environmental monitoring procedure, but the records did not clearly reconcile discrepancies between samples the firm collected and the results obtained.
Another concern was the company’s failure to establish and follow written procedures to prevent microbiological contamination of sterile drug products.
Lastly, the firm’s smoke studies do not support the assertion that it maintains unidirectional airflow for all aseptic operations to safeguard drugs against potential contamination.
The FDA asked the companies to specify how they intend to correct the violations and prevent recurrences.
In addition, Antibioticos do Brasil must provide the agency a comprehensive evaluation of the adequacy of its processing line design and control; an assessment of operator aseptic techniques; a comprehensive evaluation of its environmental monitoring process; and an interim plan to ensure its drugs meet quality standard.
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