FDA Inspection
Drive DeVilbiss HealthcareFDA Inspection 798340 - Drive DeVilbiss Healthcare - August 31, 2012
Record Details
This FDA Inspection record concerns Drive DeVilbiss Healthcare, with an inspection on August 31, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Drive DeVilbiss Healthcare
- Inspection Date
- August 31, 2012
- Product Type
- Devices
View Company Profile
ID · 53dcde03-758d-453d-8200-67cb311aa3f2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 798340
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Drive DeVilbiss Healthcare
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 18, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Drive DeVilbiss Healthcare
- FDA Inspection 959263 - 2016-02-24
- FDA Inspection 888233 - 2014-07-18
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