2. Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).
Our investigator observed employees working in gowns that had unraveled stitching extending from hoods, zippers, and pants. Your firm approved these gowns for operations. Employees wore them while manufacturing sterile [redacted] USP API and sterile [redacted] API. Five of 10 garments released for use in aseptic production areas had loose fibers or other damage. Per your procedures, you should have discarded these garments. You determined that inadequate lighting and ineffective operator training were root causes.
Your response is inadequate because it does not include your assessment of washing, drying, ironing, sterilizing, or other operations that may contribute to sterile garment damage. It also does not address the need to limit the number of sterilizations. Our investigator noted that you sterilize gowns numerous times. These excessive sterilizations lead to breakdown of gown fibers.
Your aseptic processing gowns were inadequate to prevent contamination of your sterile products with particles and microorganisms shed from employees’ bodies. Your firm must use garments that are suitable for aseptic processing....
Wednesday, January 4, 2017
Warning Letter of the Week: loose fibers edition
A missive to Dr. Habil Khorakiwala, the Founder, Chairman and Group CEO of Wockhardt Limited in Mumbai from the folks at the Center for Drug Evaluation and Research:
There's many a slip 'twixt the cup and the lip...