FDA Inspection 1001610 — Jack Kwarecki, M.D.
The FDA completed an inspection of Jack Kwarecki, M.D. on Jan 19, 2017 in Barska 16/20 02-315 Warszawa. 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
- Jan 19, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Barska 16/20 02-315 Warszawa (Poland)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7389 | 21 CFR 50.25(a)(3) | Benefits to the subject |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |