FDA Inspection 886802 — Mayo Clinic PET Radiochemistry Facility
The FDA completed an inspection of Mayo Clinic PET Radiochemistry Facility on July 11, 2014 in Rochester, MN. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rochester, MN (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6830 | 21 CFR 314.80(c)(2) | Interval |