An animated operator has helped land Gilead an FDA warning letter. But the company was cited for a variety of violations that go beyond operator antics.
In the late September letter, which stems from an inspection at the beginning of the year of the company's San Dimas, CA, facility, the regulator cites the drugmaker for an instance of an excited aseptic fill operator who neglected procedures intended to prevent microbiological contamination of drug products. The procedures call for personnel "to make slow, deliberate movements during manufacturing operations," the letter states. Inspectors noted, however, an operator "making excessive body and hand movements and engaging in animated conversations."
Among the other violations is failure to maintain defined operations areas to prevent contamination and product mix-ups; a sub-par airflow assessment technique; inadequate written procedures for controls that assure product identity, strength, quality and purity; and lack of investigation into a product failure. The latter case involves tablet-process re-validation lots that repeatedly failed visual inspection. Rather than investigating the cause, operators culled defective tablets and packaged the remainder, according to the letter.
- here's Warning Letter W/L 44-10