FDA Inspection 1264085 — Deborah A. Goss, M.D.
The FDA completed an inspection of Deborah A. Goss, M.D. on Mar 17, 2025 in Hackensack, NJ. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 17, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Hackensack, NJ (United States)
Additional details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 3007 | 21 CFR 812.140(d) | Record retention inadequate |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |