FDA Inspection 968956 — Manhattan Fertility Services LLC
The FDA completed an inspection of Manhattan Fertility Services LLC on April 11, 2016 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2016
- Fiscal Year
- 2016
- 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 |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |