FDA Inspection
Jack Kwarecki, M.D.Jack Kwarecki, M.D. – FDA Inspection, Jan 19, 2017
Record Details
This FDA Inspection record concerns Jack Kwarecki, M.D., with an inspection on January 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · b5bcfb7d-1ac2-4909-9540-770c8589955a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1001610
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 50.25(a)(3)Benefits to the subject
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.