FDA Inspection
CPAPNEA Medical SupplyCPAPNEA Medical Supply – FDA Inspection, Jul 30, 2019
Record Details
This FDA Inspection record concerns CPAPNEA Medical Supply, with an inspection on July 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3104ff4b-866f-4027-a89f-5f57d75193aa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1099278
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 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 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of CPAPNEA Medical Supply
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for CPAPNEA Medical Supply
- FDA Inspection 1131041 - 2020-10-07
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