FDA Inspection 858296 — New York Reproductive Wellness Medicine, P.C.
The FDA completed an inspection of New York Reproductive Wellness Medicine, P.C. on December 10, 2013 in Syosset, NY. 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
- December 10, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Syosset, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |