FDA Inspection 662101 — Cooper Institute For Reproductive Hormonal Disorders, P.C.
The FDA completed an inspection of Cooper Institute For Reproductive Hormonal Disorders, P.C. on May 6, 2010 in Mount Laurel, NJ. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 6, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mount Laurel, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |