FDA Inspection
Aurora Surgical, LLCAurora Surgical, LLC – FDA Inspection, Jan 24, 2013
Record Details
This FDA Inspection record concerns Aurora Surgical, LLC, with an inspection on January 24, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aurora Surgical, LLC
- Inspection Date
- January 24, 2013
- Product Type
- Devices
View Company Profile
ID · a51b4deb-3e25-407e-b57e-395cd49724fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 815725
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 803.17Lack of Written MDR Procedures
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