Company
United StatesRegene, Lancaster, CA – FDA Inspections
Inspection records and compliance data for Regene in Lancaster, California. 2 FDA inspections on record, last inspected April 07, 2016.
Company Profile
This profile covers Regene based in Lancaster, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 13, 2013. Last inspected April 7, 2016.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Identification procedures, Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 7, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 968144 |
| March 13, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 823008 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Regene
FEI Number
3009143307
Address
123 W Avenue J5, Lancaster, California 93534, United States
Country
United States
ID: 668d33b3-0882-4027-ad90-8b34ec433f8c