FDA Inspection 654471 — Ali Guerami, MD
The FDA completed an inspection of Ali Guerami, MD on April 1, 2010 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 1, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12225 | 21 CFR 1271.47(d) | Departures: recording and justifying |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12409 | 21 CFR 1271.250(c) | Documentation of donor eligibility |
| 15024 | 21 CFR 1271.320(b) | Available for review and copying by FDA |