FDA 483 - Professional Disposables International, Inc. - August 12, 2008

This FDA Form 483 was issued to Professional Disposables International, Inc., a manufacturer located at 2 Nice Pak Park, Orangeburg, NY, following an inspection from August 6-12, 2008. The report was addressed to Robert P. Reichman, Vice President, Worldwide Quality/Regulatory Affairs.

Three observations were noted:

1. **Laboratory records lacked review for accuracy and completeness.** Specifically, microbiological testing of purified water failed to follow SOP WI QAS-028. This led to instances where out-of-specification (OOS) results (e.g., positive for Pseudomonas and other bacteria on 7/14/08 for Ports (b)(4) and (b)(4)) were reported as negative, and the water was subsequently released for manufacturing without investigation.

2. **Procedures for handling drug product complaints were not followed.** The firm failed to adhere to SOP QAS-001 and SOP QAS-027. Numerous complaints were not closed within required timeframes, lacking written justification for delays (some were months late). Additionally, investigations were inadequate; for example, retain samples were not checked, or complaints were closed without attempting to retrieve further information on possible serious adverse events.

3. **Procedures for warehousing drug products were not established and followed.** * No written procedures existed to ensure appropriate storage conditions, such as monitoring or recording temperatures