FDA Warns Compounding Pharmacy for Lax Aseptic Processing
The FDA delivered its fifth warning letter to a compounding pharmacy in roughly two weeks, admonishing a Texas compounder for poor aseptic processing of sterile drugs.
The letter chides Abrams Royal Pharmacy for numerous quality violations uncovered during a December 2013 inspection of its Dallas, Texas, compounding facility.
Chief among them was the use of non-sterile gowns and gloves that exposed the wrists and nose. Employees were observed picking up items off the floor and continuing to process drugs without changing gloves or sanitizing their hands, said the July 14 letter.
In addition, Abrams failed to demonstrate that its hoods used in the clean room adequately protect sterile drugs from contamination, and employees didn’t use a sporicidal cleaning agent to disinfect the clean room, the letter said.
Abrams also compounded drugs without a prescription, a common finding in agency enforcement of large compounding pharmacies.
The compounder recalled all of its sterile products and agreed to cease production of sterile drugs following the December inspection. To resume operations, Abrams must meet good manufacturing practices for drug manufacturing, the FDA said. The company also should hire a third-party consultant with expertise in sterile drug manufacturing to assist with a comprehensive evaluation of its operations, the letter added.
The FDA also took the unusual step of ensuring that Abrams check the quality of its contractors. The compounder hired an unnamed contract testing laboratory to perform required testing on finished drug products, however the lab was cited by the FDA in 2012 and 2013 for serious GMP violations, the letter said.
The compounder warning is the latest signal that the agency intends to make full use of its new oversight powers granted under a November 2013 law. Abrams did not return a request for comment as of press time.
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