FDA Inspection 787333 — Balin, Martin S., MD, PhD
The FDA completed an inspection of Balin, Martin S., MD, PhD on August 17, 2012 in Chicago, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 17, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12494 | 21 CFR 1271.85(c) | Reproductive cells or tissues |