FDA Inspection 979895 — Francis Polansky, M.D., Inc
The FDA completed an inspection of Francis Polansky, M.D., Inc on July 8, 2016 in Palo Alto, CA. 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
- July 8, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Palo Alto, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |