FDA issues warning letter to Gilead Sciences over quality control problems at Calif. plant

FDA warns Gilead Sciences over quality controls

WASHINGTON — Federal health regulators are warning biotech drug maker Gilead Sciences Inc. about quality control violations at a California factory.

The Food and Drug Administration on Tuesday posted a warning letter on its website, outlining more than a half-dozen problems uncovered by inspectors on a routine visit to Gilead’s San Dimas, Calif., facility.

The Sept. 21 letter says Gilead does not have written procedures to prevent bacterial contamination of its drugs. The inspectors also note that Gilead repeatedly failed to investigate when batches of pills “failed visual inspection.” In addition, they say the company did not properly clean or maintain equipment.

FDA inspectors visited the plant early in the year, and Gilead responded to those criticisms in March. But the FDA says the firm’s response “lacks sufficient corrective actions.”

The FDA is asking the company to update the agency on the corrective steps it is taking within 15 days of receiving the letter.

Gilead sells the market-dominant HIV drugs Atripla and Truvada.

“We are now closely evaluating the information in the warning letter and intend promptly to address any outstanding issues as quickly as possible,” company spokesman Nathan Kaiser said in a statement.

Gilead disclosed the warning letter in a regulatory filing Sept. 24 and said the letter could affect its ability to export AmBisome, which is injected and treats fungal infections. Gilead said the FDA action should not affect its solid-form drugs, including Atripla and Truvada.

The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing, marketing and testing. The letters are not legally binding, but the agency can take companies to court if they ignore the letters.

Gilead shares rose 68 cents to $36.04 in midday trading.