FDA Inspection
OCO Biomedical, Inc.OCO Biomedical, Inc. – FDA Inspection, Jan 25, 2011
Record Details
This FDA Inspection record concerns OCO Biomedical, Inc., with an inspection on January 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OCO Biomedical, Inc.
- Inspection Date
- January 25, 2011
- Product Type
- Devices
View Company Profile
ID · 9a1e9207-afdf-4924-a318-012dc0d61d00
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 706869
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OCO Biomedical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 14, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 30, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 15, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for OCO Biomedical, Inc.
- FDA Inspection 1050211 - 2018-04-04
- FDA Inspection 1049006 - 2018-02-14
- FDA Inspection 912013 - 2015-01-30
- FDA Inspection 899868 - 2014-10-15
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