FDA Inspection
Winfield Laboratories, Inc.Winfield Laboratories, Inc. – FDA Inspection, Sep 25, 2018
Record Details
This FDA Inspection record concerns Winfield Laboratories, Inc., with an inspection on September 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 9397709a-2325-4fd8-840e-4c4f539a167b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066676
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
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.