FDA Inspection
Bharat EnterprisesBharat Enterprises – FDA Inspection, Mar 20, 2013
Record Details
This FDA Inspection record concerns Bharat Enterprises, with an inspection on March 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bharat Enterprises
- Inspection Date
- March 20, 2013
- Product Type
- Devices
View Company Profile
ID · 77857d04-a0d8-4a05-9f23-de32d841c838
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 825001
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.86Acceptance status
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