# FDA WARNING_LETTER - Boukhari Prince Medical BPM sa - April 02, 2012

Source: https://www.keypedia.com/records/warning_letter/boukhari-prince-medical-bpm-sa/52defc69-d2b0-4469-9e67-000248ab4711

> FDA WARNING_LETTER for Boukhari Prince Medical BPM sa on April 02, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Boukhari Prince Medical BPM sa
- Inspection Date: 2012-04-02
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On March 29-31 and April 2, 2012, an FDA inspection of Boukhari Prince Medical BPM sa in Bizerte, Tunisia, revealed that their Urodynamic Catheters and Regulator Administration Sets are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's April 23, 2012, response to the FDA 483 was deemed inadequate.

Key violations include:
1.  **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate processes, specifically for (b)(4), lacking a documented validation plan and general validation procedure. The firm's proposed plan lacked implementation evidence or global corrective actions.
2.  **Purchasing Controls (21 CFR 820.50(a)):** Failure to establish and maintain adequate supplier requirements; (b)(4) of reviewed suppliers were not evaluated or on the approved list. Proposed procedure updates lacked implementation evidence.
3.  **Complaint Handling (21 CFR 820.198(a)):** Inadequate procedures for receiving, reviewing, and evaluating complaints. The procedure did not define a complaint, commingled device complaints with non-conformances, and failed to require MDR

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/boukhari-prince-medical-bpm-sa/0174266d-9cab-4cce-b4b4-94e6df29b6da

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7