# FDA WARNING_LETTER - Husain, Mustafa M, M.D. - March 07, 2008

Source: https://www.keypedia.com/records/warning_letter/husain-mustafa-m-md/0ebef7a3-0d84-4841-a797-d2a54ee1e464

> FDA WARNING_LETTER for Husain, Mustafa M, M.D. on March 07, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Husain, Mustafa M, M.D.
- Inspection Date: 2008-03-07
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: This FDA Warning Letter, dated September 10, 2008, informs Dr. Mustafa M. Husain of serious violations identified during an inspection of his clinical site from March 4-7, 2008. The inspection assessed compliance with 21 CFR Part 50 (Protection of Human Subjects) and Part 812 (Investigational Device Exemptions) for the clinical study [redacted] Investigational Device Exemption (IDE) [redacted], involving a [redacted] device.

Violations include:
1.  **Failure to conduct the investigation according to the signed agreement, investigational plan, and applicable FDA regulations** (21 CFR 812.100 and 812.110(b)). Specifically, subjects [redacted] and [redacted] did not complete the protocol-required [redacted] period of [redacted] days, which could decrease the [redacted] threshold and result in prolonged [redacted]. Dr. Husain's response acknowledging the deviation was deemed inadequate as it lacked documentation of corrective or preventative actions.
2.  **Failure to maintain accurate, complete, and current records and submit required reports** (21 CFR 812.140(a)(1), 812.140(a)(2)(i)(iii), 812.150(a)(

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