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

Source: https://www.globalkeysolutions.net/records/483/professional-disposables-international-inc/903c78c7-8573-46d0-82b4-c9827c62fc79

> FDA 483 for Professional Disposables International, Inc. on August 12, 2008. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Professional Disposables International, Inc.
- Inspection Date: 2008-08-12
- Office Name: New York District Office
- Summary: 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

## Related Documents

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- [WARNING_LETTER - 2021-06-23](https://www.globalkeysolutions.net/records/warning_letter/professional-disposables-international-inc/8825c59a-02af-4b98-9e13-1e8ac8669bdf)
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## Related Officers

- [Demitria J. Argiropoulos](https://www.globalkeysolutions.net/people/demitria-j-argiropoulos/033be1fb-0c6b-48a7-97a3-a4e3efbfebbe)

Company: https://www.globalkeysolutions.net/companies/professional-disposables-international-inc/d376f414-c76e-440c-9fbf-f21b65260c53

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d