FDA Inspection 983668 — Cyclotron Facility University Of Pennsylvania
The FDA completed an inspection of Cyclotron Facility University Of Pennsylvania on Jun 30, 2016 in Philadelphia, PA. 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
- Jun 30, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17722 | 21 CFR 212.10 | Lack Adequate Resources, Facilities, Equipment. |
| 17742 | 21 CFR 212.30(b) | Equipment not suitable |
| 17757 | 21 CFR 212.20(b) | Examine, approve or reject |
| 17759 | 21 CFR 212.20(c) | Adverse effects of changes made |
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |