FDA Inspection
DIGITAL HEAT CORPORATIONDIGITAL HEAT CORPORATION – FDA Inspection, Dec 13, 2017
Record Details
This FDA Inspection record concerns DIGITAL HEAT CORPORATION, with an inspection on December 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 14fdf82f-86a0-4d26-80c8-4f42a7988b86
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1035623
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate 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 820.30(a)Design control - no procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of DIGITAL HEAT CORPORATION
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DIGITAL HEAT CORPORATION
- FDA Inspection 1089546 - 2019-03-13
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