FDA Inspection
OnCore Manufacturing LlcOnCore Manufacturing Llc – FDA Inspection, Nov 19, 2010
Record Details
This FDA Inspection record concerns OnCore Manufacturing Llc, with an inspection on November 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OnCore Manufacturing Llc
- Inspection Date
- November 19, 2010
- Product Type
- Devices
View Company Profile
ID · 379fb02f-56f4-40d9-bae1-4437d4b32c59
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 698474
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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