FDA Inspection 957595 — Northampton Hospital Corporation d.b.a. Easton Hospital
The FDA completed an inspection of Northampton Hospital Corporation d.b.a. Easton Hospital on February 4, 2016 in Easton, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Easton, PA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |