FDA Inspection
Waclaw B. Kuczmik, M.D. PhDWaclaw B. Kuczmik, M.D. PhD – FDA Inspection, Feb 14, 2025
Record Details
This FDA Inspection record concerns Waclaw B. Kuczmik, M.D. PhD, with an inspection on February 14, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Waclaw B. Kuczmik, M.D. PhD
- Inspection Date
- February 14, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 552c8f06-dc87-4764-adcc-4d22afd1908e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1260885
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(3)Investigator's subject records inadequate
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.