FDA Inspection
Meditherm Inc.Meditherm Inc. – FDA Inspection, May 30, 2018
Record Details
This FDA Inspection record concerns Meditherm Inc., with an inspection on May 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ee3b13fb-f4ab-4646-b469-9322c3a35b81
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1053769
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Meditherm Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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