FDA Inspection 605575 — Mary Martini, MD
The FDA completed an inspection of Mary Martini, MD on Aug 21, 2009 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 21, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Chicago, IL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14508 | 21 CFR 812.140(a)(4) | Investigator record of protocol deviations inadequate |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |