FDA 483 - Professional Disposables International, Inc. - July 05, 2011

During an inspection from June 22, 2011, to July 5, 2011, the FDA observed deficiencies at Professional Disposables International, Inc., a manufacturer located at 2 Nice Pak Park, Orangeburg, NY. The inspection report was issued to Mr. Robert P. Reichman, Vice President Worldwide Quality/Regulatory Affairs.

Observation 1 noted that each lot of a component liable to microbiological contamination is not subjected to microbiological tests before use. Specifically, Bacillus spp. was found in PDI alcohol prep pads (Lot# 11100055) linked to a patient's bacteremia. The company confirmed Bacillus cereus in this and other lots (11100515, 11003269, 11003222, 11002166). Root cause analysis indicated Bacillus cereus recovery from the applicator. However, the corrective action plan for non-conformance report #NYH-11-0131 did not propose microbiological testing for each lot of applicators used in both non-sterile and sterile alcohol prep pads, despite Work Instruction QAS-012.

Observation 2 identified that the written stability program for drug products lacks test intervals based on statistical criteria for each attribute, failing to assure valid stability estimates throughout the proposed shelf life. This deficiency means potential out-of-specification microbiological