FDA Inspection 828995 — CNY Fertility Colorado PLLC
The FDA completed an inspection of CNY Fertility Colorado PLLC on Apr 24, 2013 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 24, 2013
- Fiscal Year
- 2013
- 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 |
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |