Company
United StatesUnicare Biomedical, Inc., Laguna Hills, CA – FDA Inspections
Inspection records and compliance data for Unicare Biomedical, Inc. in Laguna Hills, California. 7 FDA inspections on record, 1 Form 483, last inspected July 28, 2026.
Company Profile
This profile covers Unicare Biomedical, Inc. based in Laguna Hills, California, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 1, 2011. Last inspected July 28, 2026.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 28, 2026 | NAI | · Human Cellular, Tissue, and Gene Therapies | 1329140 |
| March 6, 2024 | Not classified | Medical Devices & Rad Health | 1234094 |
| June 28, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1174261 |
| May 11, 2022 | NAI | Biologics · Vaccines and Allergenic Products | 1169384 |
| April 13, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 974365 |
| May 9, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 830902 |
| March 1, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 713226 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Unicare Biomedical, Inc.
FEI Number
3003646540
Address
23011 Moulton Pkwy Ste J11, Laguna Hills, California 92653, United States
Country
United States
ID: cc3f9395-4e68-436b-b11b-f80b725a903b