Company
United StatesHelena Laboratories, Inc, Beaumont, TX – FDA Inspections
Inspection records and compliance data for Helena Laboratories, Inc in Beaumont, Texas. 3 FDA inspections on record, last inspected July 14, 2017.
Company Profile
This profile covers Helena Laboratories, Inc based in Beaumont, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 28, 2010. Last inspected July 14, 2017.
Most cited issue areas
- Design verification - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 14, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1029048 |
| March 1, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 820619 |
| October 28, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 695366 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Helena Laboratories, Inc
FEI Number
1000116989
Address
3795 Washington Blvd, Beaumont, Texas 77705, United States
Country
United States
ID: 9fec945b-1553-4aed-9026-6cc02a33a43a