FDA Warns Compounder for Extensive Quality Violations
The FDA has warned a Mississippi compounder for not disinfecting its clean room equipment and for other serious manufacturing violations, capping a busy year for the agency’s compounding pharmacy enforcement.
The warning letter to Delta Pharma, stems from a 2013 inspection of the company’s facility that was prompted by four adverse event reports of patients taking its eye injection solution triamcinolone and lidocaine.
Employees used unsterile disinfectants in the clean room and did not disinfect equipment before putting it in the clean room area, potentially leading to contamination, the agency said. In addition, the design of Delta’s clean room doesn’t prevent potentially contaminated air from circulating in the area, according to the letter issued Dec. 9.
Delta volunteered in August to become an “outsourcing facility” under a 2013 federal law, which allowed it to make drugs without a prescription as long as it adhered to good manufacturing practice related to compounding. These included a set of interim GMPs related to aseptic processing while the agency drafted compounding-specific GMPs.
Delta told the FDA it is in compliance with those interim GMPs, but the agency disagreed. The FDA found pressure in the clean room and gowning area didn’t meet minimum specifications and called the company’s air flow study inadequate.
The agency has warned nearly 30 compounders this year for similar violations of poor aseptic processing and other violations.
Don’t get hit with warning letters like this one. Make sure your employees know the importance of the cleanroom environment and the need to maintain the integrity of cleanrooms with Introduction to Contamination Control.