FDA Inspection 1046103 — UPMC Susquehanna Williamsport Regional Medical Center
The FDA completed an inspection of UPMC Susquehanna Williamsport Regional Medical Center on Mar 29, 2018 in Williamsport, 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Williamsport, PA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7277 | 21 CFR 56.107(d) | One non-affiliate member |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |