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.
Meanwhile, investigators from the FDA’s Detroit office twice inspected Pharmakon’s facility, in March and April 2014, after receiving adverse event reports of over-sedation in neonatal infants who had been given midazolam labeled with an incorrect concentration. The problem stemmed from a failure to establish that drug products met proper specifications, the warning letter says.
The FDA dinged HSSC for not monitoring employees charged with producing sterile drug products during a July 14 to 28, 2014, inspection.
Investigators from the Florida district office also noted the firm had unsealed ceiling tiles. Responding to a Form 483, the company said sealing the tiles would render HEPA filters inaccessible, but the FDA said the filters should be accessible with the tiles sealed.
The FDA urged the compounders to hire outside consultants with sterile drug manufacturing expertise to bring their facilities into compliance.
Since the start of the year, the FDA has warned compounders in Florida, Kentucky, New York, Kansas and Oregon over poor sterility controls.
None of the compounders returned a request for comment by press time. View the warning letters to Premier Pharmacy, HHCS and Pharmakon at www.fdanews.com/06-03-15-Premier.pdf, www.fdanews.com/06-03-15-HHCS.pdf and www.fdanews.com/06-03-15-Pharmakon.pdf, respectively. — Kellen Owing