Gilead is latest drugmaker in FDA’s sights
pharmafile | August 13, 2010 | News story | Manufacturing and Production | Gilead, cystic fibrosis, manufacturing compliance
A manufacturing and distribution facility operated by US biotech Gilead Sciences is at risk of receiving a warning letter from the FDA unless management can bring it back up to scratch.
The plant in San Dimas, California, underwent a routine inspection by the US regulator in January and February 2010 which resulted in a number of deficiencies being recorded via a Form 483 (a notice of inspectional observations).
The issues uncovered by the inspectors included problems with the maintenance of aseptic processing conditions in the manufacturing suite for Gilead’s antifungal product AmBisome (liposomal amphotericin B), as well as environmental maintenance issues in the site’s warehousing facility.
In addition to AmBisome which brought in $155 million of the firm’s total sales of $3.6 billion in the first six months of 2010, the San Dimas site also makes Gilead’s cystic fibrosis treatment Cayston (aztreonam for inhalation) and provides filling and finishing of the firm’s Macugen (pegaptanib sodium injection) for age-related macular degeneration, a leading cause of blindness.
The manufacturing problems do not appear to affect any of Gilead’s HIV treatments Truvada, Atripla and Viread, which account for the bulk of its sales and are packaged at the San Dimas facility.
The Form 483 also detailed some concerns with batch sampling practices and the timeliness of completion of annual product quality reports, according to a document filed by Gilead with the US Securities & Exchange Commission (SEC).
In the filing, Gilead says that the FDA is considering sending out a formal warning letter although it also says it believes it has addressed all the concerns in the Form 483.
“If the FDA issues a warning letter to us, it could affect our ability to receive export certificates or approvals of regulatory applications associated with the products at issue in the warning letter,” says the company.
Phil Taylor
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