FDA Inspection 840036 — Hudson Valley Fertility, PLLC
The FDA completed an inspection of Hudson Valley Fertility, PLLC on Jul 18, 2013 in Fishkill, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 18, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fishkill, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12225 | 21 CFR 1271.47(d) | Departures: recording and justifying |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |