FDA Inspection 907753 — Cooper Institute for Advanced Reproductive Medicine
The FDA completed an inspection of Cooper Institute for Advanced Reproductive Medicine on December 22, 2014 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 22, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |