Company
United States2h Manufacturing & Distribution Corp, Irvine, CA – FDA Inspections
Inspection records and compliance data for 2h Manufacturing & Distribution Corp in Irvine, California. 1 FDA inspection on record, last inspected June 22, 2011.
Company Profile
This profile covers 2h Manufacturing & Distribution Corp based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected June 22, 2011.
Most cited issue areas
- Lack of System for Determining MDR Events1 inspection
- Lack of System for Event Evaluations1 inspection
- Lack of System for Timely Submission of Reports1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 22, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 730769 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
2h Manufacturing & Distribution Corp
FEI Number
3005353770
Address
2082 Business Center Dr Ste 175, Irvine, California 92612, United States
Country
United States
ID: 52392c6f-c6d8-4caa-be48-c96f27ecf006