Company
United StatesOCO Biomedical, Inc., Albuquerque, NM – FDA Inspections
Inspection records and compliance data for OCO Biomedical, Inc. in Albuquerque, New Mexico. 5 FDA inspections on record, last inspected April 04, 2018.
Company Profile
This profile covers OCO Biomedical, Inc. based in Albuquerque, New Mexico, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected January 25, 2011. Last inspected April 4, 2018.
Most cited issue areas
- Design history file1 inspection
- Documentation1 inspection
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 4, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1050211 |
| February 14, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1049006 |
| January 30, 2015 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 912013 |
| October 15, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 899868 |
| January 25, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 706869 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
OCO Biomedical, Inc.
FEI Number
1627417
Address
9550 San Mateo Blvd NE Ste C, Albuquerque, New Mexico 87113, United States
Country
United States
ID: ba2f30f1-413c-4e71-beae-dc0d61ac8acb