Gilead SEC filing anticipates FDA warning letter

HIV treatment maker Gilead Sciences says it soon may be the recipient of an FDA warning letter. During a routine inspection of its San Dimas, CA, facility at the beginning of the year, the regulator found maintenance and procedural problems. The company learned in May that the FDA may issue the warning, according to the Wall Street Journal.

Inspectors reportedly found sub-par aseptic processing conditions, batch sampling anomalies, warehouse maintenance issues and late product-quality reports. The manufacturing problems, which the company says it believes it has corrected, were identified in an SEC filing.

The facility is where Gilead makes fungal infection treatment AmBisome, which it sells with Astellas Pharma, and Cayston, an inhaled antibiotic. The company uses the facility also for end-stage manufacturing of eye-disease treatment Macugen.

- here's the article (subscription required)
- see the filing

Suggested Articles

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.

Continuing its expansion efforts, Japan’s Fujifilm will make a major investment in its U.S. gene therapy operation in Texas.