Texas Pharmacy Warned on Sterility and More GMP Violations

July 17, 2017

A complaint about ineffective erectile dysfunction drugs led to an FDA inspection of a Texas-based compounder, resulting in 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.

More GMP violations relating to quality and sterility detailed in the letter also included: failure to establish and follow written procedures to prevent microbiological contamination; failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas; and failure to properly test drugs for stability or maintain batch records on drug specifications, stability and sterility.

The compounder was issued a Form 483 for the violations in December 2015 and the corrective actions taken were insufficient, including a lack of documentation, according to the warning letter.

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