FDA Inspection 796132 — Sher Fertility Solutions New York
The FDA completed an inspection of Sher Fertility Solutions New York on August 31, 2012 in New York, 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
- August 31, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |