FDA Inspection
EXALT DEVICES LLCEXALT DEVICES LLC – FDA Inspection, Jan 8, 2016
Record Details
This FDA Inspection record concerns EXALT DEVICES LLC, with an inspection on January 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EXALT DEVICES LLC
- Inspection Date
- January 8, 2016
- Product Type
- Devices
View Company Profile
ID · 920da0a8-8917-4fa3-b2b3-4ba01056a63d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 957605
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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