Unsanitary Sterile Processing Results in Warning for Compounder

June 13, 2014

Unsanitary lab coats, hairnets and facemasks were among the problems cited in a warning letter to compounding pharmacy Medaus, the latest compounder to receive a warning from the FDA.

The warning letter details a litany of good manufacturing practice violations such as unsanitary processing procedures. The company also was warned for making drugs without a prescription; a common violation for compounding pharmacies.

The warning letter, issued in January, stems from a March 2013 Form 483 that followed an inspection of the company’s Birmingham, Ala., facility.

Agency investigators observed technicians wearing “non-sterile laboratory coats, hairnets, beard covers and facemasks while performing aseptic processing,” the warning letter reads. “In addition, investigators observed technicians performing aseptic processing with exposed skin.”

The FDA also found that Medaus labels products with expiration dates of up to 180 days in the future, expirations that have not been established by appropriate stability testing.

The warning letter cites new authorities that the agency has over compounders following passage of the 2013 Drug Quality and Security Act.

Medaus refuted the GMP violations, noting that the garments used by employees and the aseptic processing practices meet U.S. Pharmacopeia regulations, Hube Dodd, corporate counsel for Medaus, said.

Dodd also objected to a finding that the pharmacy’s clean room includes unsealed panels and lacks HEPA filters. He said the finding is untrue, as the company does have HEPA filters in that area and has also since upgraded its system.

He said that after the warning letter was issued in January the pharmacy responded to the agency noting how it addressed the concerns. The pharmacy has yet to receive a response, Dodd said.

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