FDA Inspection 926250 — Fisher Bioservices IRB
The FDA completed an inspection of Fisher Bioservices IRB on May 14, 2015 in Rockville, MD. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 14, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Rockville, MD (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |