The FDA has warned three more drug compounding pharmacies over sterility issues and other GMP shortcomings, bringing to 12 the number cited since October.
Florida-based Premier Pharmacy Labs and HHCS Pharmacy and Noblesville, Ind.-based Pharmakon Pharmaceuticals were cited for failing to maintain sterile rooms for manufacturing and failing to establish and follow procedures for preventing contamination.
During an April 10 to May 9, 2014, inspection of Premier facility, investigators from the FDA’s Florida district office noted the firm failed to investigate drug batches that didn’t meet specifications, regardless of whether the batches had been distributed.
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