Texas Pharmacy Warned on Sterility and More
A complaint about ineffective erectile dysfunction drugs launched an FDA inspection of a compounder operated by a Texas-based pharmacy chain, leading to a lengthy warning letter from the agency detailing sterility concerns.
In addition to the pharmacy's lack of valid prescriptions for some of its prepared drugs, FDA inspectors found “serious deficiencies” in sterility practices at Dougherty's Pharmacy Preston Royal location in Dallas.
Workers brought unsanitized components into ISO 7 cleanrooms and investigators noted workers with bare hands exposed in work areas where sterile drugs were being prepared during a December 2015 visit, according to the letter. The compounder also failed to sufficiently investigate batch discrepancy and failures to meet specifications, the FDA said.