Company
United StatesBright Cell Inc, Irvine, CA – FDA Inspections
Inspection records and compliance data for Bright Cell Inc in Irvine, CA. 1 FDA inspection on record, 1 Form 483, last inspected May 15, 2026.
Company Profile
This profile covers Bright Cell Inc based in Irvine, CA, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected May 15, 2026.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Actual vs. theoretical yields not determined1 inspection
- Batch production and Batch Control Record Requirements1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 15, 2026 | Not classified | Biologics · Human Cellular, Tissue, and Gene Therapies | 1293606 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bright Cell Inc
FEI Number
3029777044
Address
9321 Irvine Blvd, Irvine, CA 92618-1669, United States
Country
United States
ID: 87fa278a-9c91-472a-9ede-f08589fd8426