Gilead: FDA Reviewed, Found No Problems At San Dimas, Calif, Site

Gilead Sciences Inc. (GILD) said the Food and Drug Administration re-inspected its San Dimas, Calif., production facility late last year and found no problems at the site.

The company, known for its HIV treatments, received a warning letter from the agency last year after an inspection found multiple quality control problems. In a regulatory filing Monday, Gilead said the agency reviewed the manufacturing site in November and December and didn't issue a Form 483, which covers problems found during an inspection.

"Consequently, we believe that we have addressed the FDA's concerns ... but we are awaiting confirmation of acceptance from the FDA," Gilead said Monday.

After an initial inspection in January and February of last year, the FDA found a list of problems covering improper cleaning and maintenance, along with procedural issues. The company responded to the findings, but the FDA issued a warning letter in September because the response was inadequate and criticizing Gilead's quality-control operation.

Gilead shares fell 3 cents to $38.98 Monday.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

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