FDA Reprimands Genentech on Drugs
Dec. 27, 2000
SAN FRANCISCO (AP) _ Federal officials have reprimanded Genentech Inc. after some of its drugs for strokes, breast cancer and cystic fibrosis were found to be contaminated or exposed to unusual conditions.
The Food and Drug Administration ordered the company in a warning letter to improve quality control at its South San Francisco manufacturing plant or face fines or suspension of its license.
The drugs involved are Pulmozyme for cystic fibrosis, Herceptin for breast cancer and Activase for strokes.
Pulmozyme was found to be contaminated with traces of cellulose and stainless steel. Instead of trashing the contaminated batch, the FDA said the company refiltered the product and shipped it.
Refiltering is not an approved manufacturing technique. The FDA also rebuked the company for not investigating how the cellulose got into the drug.
Genentech recalled 200,000 doses of Pulmozyme in October.
The Activase also underwent refiltration, the FDA said.
The Herceptin was subjected to unusual conditions when a drying device malfunctioned. The FDA said Genentech did not do enough to prove that the exposure didn't affect the medicine.
The company said the rebuke was its first from the FDA in 20 years of manufacturing. The letter followed a two-week site inspection. Government inspectors remained dissatisfied with the company's efforts to fix the problems.
``We take this very seriously, and we've been working to resolve these issues,'' said Genentech spokeswoman Marie Kennedy.
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Food and Drug Administration: http://www.fda.gov