FDA 483 - US Compounding Inc - July 15, 2016

The FDA Form 483 details significant deficiencies in aseptic processing, environmental monitoring, facility design, and quality control at the inspected facility.

**Environmental Monitoring Deficiencies:** * Failure to investigate increasing mold recoveries from March to June 2016. * Lack of investigation or action for large, fuzzy mold colonies observed on environmental monitoring plates. * Inconsistent surface sampling practices (e.g., operators conducting sampling directly above surfaces). * Environmental monitoring using plates was only conducted in an unused, cleaned cleanroom for the week of 07/04/2016. * Inability to demonstrate the effectiveness of operator glove sanitization.

**Aseptic Processing Area Deficiencies (Air Supply/Pressure):** * Routine failure to maintain pressure differentials, with frequent excursions (e.g., negative pressure between ISO 7 Cleanroom and ISO 7 Anteroom during processing of Methylprednisolone Acetate PF). * Missing time points in pressure logs (e.g., 29% missing on 05/02/2016 during processing of Neostigmine Methylsulfate and MIC # B12 lots). * Failure to investigate pressure excursions (e.g., Methylprednisolone Acetate PF lot #20160109@3 distributed without investigation). * Failure to capture pressure differential losses on document QF