Company
United StatesHelena Laboratories, Corp., Beaumont, TX – FDA Inspections
Inspection records and compliance data for Helena Laboratories, Corp. in Beaumont, Texas. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected December 14, 2018.
Company Profile
This profile covers Helena Laboratories, Corp. based in Beaumont, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected October 29, 2010. Last inspected December 14, 2018.
Most cited issue areas
- Documentation2 inspections
- Maintenance schedule, Lack of or inadequate schedule2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1074463 |
| July 21, 2017 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1018711 |
| March 1, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 820597 |
| October 29, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 694963 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Helena Laboratories, Corp.
FEI Number
1618982
Address
1530 Lindbergh Dr, Beaumont, Texas 77707, United States
Country
United States
ID: 9742bc61-dee7-4b93-a33a-0581bd422d44