FDA Inspection 813223 — Reproductive Gynecology Laboratories
The FDA completed an inspection of Reproductive Gynecology Laboratories on January 15, 2013 in Akron, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 15, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Akron, OH (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 |