FDA Inspection 1025976 — Ernest Orlando Lawrence Berkeley National Laboratory RDRC
The FDA completed an inspection of Ernest Orlando Lawrence Berkeley National Laboratory RDRC on Sep 21, 2017 in Berkeley, CA. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 21, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Berkeley, CA (United States)
Additional details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17958 | 21 CFR 361.1(c)(2) | Signatures of RDRC Chairman |
| 17962 | 21 CFR 361.1(c)(2) | Numerical votes not in the minutes of any RDRC meetings |
| 17964 | 21 CFR 361.1(c)(2) | RDRC did not meet at least once each quarter |
| 17968 | 21 CFR 361.1(c)(3) | FDA research proposals not reported +30 subjects |
| 17993 | 21 CFR 361.1(f)(1) | Packaging, labeling - Rx only |
| 17997 | 21 CFR 361.1(f)(5) | Label - radioactivity, amount |