FDA Inspection 1062085 — Advanced Reproductive Center of Hawaii
The FDA completed an inspection of Advanced Reproductive Center of Hawaii on August 10, 2018 in Honolulu, HI. 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
- August 10, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Honolulu, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |