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Maintenance and procedural problems at a Gilead Sciences Inc. manufacturing and distribution facility could land the HIV drug maker a warning letter from the Food and Drug Administration.

In a Securities and Exchange Commission filing Monday, Foster City-based Gilead (NASDAQ: GILD) said a routine FDA inspection of its San Dimas facility in February raised concerns from the agency about maintenance of aseptic processing conditions in the manufacturing area for its AmBisome anti-fungal product. The agency also cited environmental maintenance issues in the warehouse, batch sampling and the timeliness of completion of annual product quality reports.

Gilead, which said it has addressed all of the FDA’s concerns, learned in May that the agency “may be considering” issuing a warning letter as a result of the inspection, according to the SEC filing guaranteed payday loan.

A warning letter could hurt Gilead’s ability to receive export certificates or approvals of regulatory applications associated with “the products at issue,” the company said, and “decrease our revenues and harm our business.”

Gilead makes AmBisome and Cayston, a recently approved inhaled drug to treat cystic fibrosis symptoms, at San Dimas. It also fills and finishes Macugen, an injectable drug marketed by Eyetech Inc. to treat age-related macular degeneration, at the facility.

AmBisome had sales of $155.2 million in the first half, Gilead’s largest-selling drug outside of its antiviral products.

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