FDA Issues Alert After Calif. Pharmacy Refuses to Recall Sterile Drugs

The FDA issued a public safety alert after a compounding pharmacy refused to recall products following a failed inspection.

FDA investigators inspected Park Compounding Pharmacy’s Westlake Village, Calif., facility between Aug. 31 and Sept. 11 and found numerous issues with sterile controls. According to a Form 483, environmental and pest controls weren’t in place, and there were numerous stains on equipment and filters. Cleaning and disinfecting processes also weren’t up to par.

Park also failed to validate its sterilization method for bottles and vials, and didn’t adequately document a media fill study, the 483 says. There were also instances of Prostaglandin being placed in unsanitized containers and of drugs being given incorrect expiration dates not backed up by stability data.

On Sept. 29, the FDA ordered the compounder to cease business until the problems were fixed and recall all of its nonexpired sterile products.

Park notified the agency the following day that it had shuttered its sterile operations but refused to recall its products, which are not considered serious health risks.

Park did not respond to a request for comment by press time. Read the Form 483 at www.fdanews.com/Park-Compounding-Inspection.pdf.  — Victoria Pelham