FDA Inspection
Auxein medical Private limitedAuxein medical Private limited – FDA Inspection, Jun 8, 2017
Record Details
This FDA Inspection record concerns Auxein medical Private limited, with an inspection on June 8, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 8, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ebeffe0d-ca48-405d-a197-f9f0dba29722
Inspection Facts
- Inspection number
- 1013377
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.75(a)Documentation
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