FDA Inspection 980606 — CNY Fertility Colorado PLLC
The FDA completed an inspection of CNY Fertility Colorado PLLC on Jan 26, 2016 in Colorado Springs, CO. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12243 | 21 CFR 1271.55(d)(1) | Documentation maintained (general) |