FDA Inspection
Wintech Medipro LLCWintech Medipro LLC – FDA Inspection, May 22, 2023
Record Details
This FDA Inspection record concerns Wintech Medipro LLC, with an inspection on May 22, 2023, issued by the Dallas District Office.
- Company
- Wintech Medipro LLC
- Inspection Date
- May 22, 2023
View Company Profile
ID · 3d460947-0559-44a7-a033-4f37a3d51e91
Inspection Facts
- Inspection number
- 1205967
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
Showing 10 of 13 citations.
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Other FDA inspections of Wintech Medipro LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 6, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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