Company
United StatesGeneral Hearing Instruments Inc, Harahan, LA – FDA Inspections
Inspection records and compliance data for General Hearing Instruments Inc in Harahan, Louisiana. 4 FDA inspections on record (1 OAI), 1 warning letter, last inspected May 03, 2024.
Company Profile
This profile covers General Hearing Instruments Inc based in Harahan, Louisiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 1
First inspected August 6, 2010. Last inspected May 3, 2024.
Most cited issue areas
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 3, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1229649 |
| January 19, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 984407 |
| August 15, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 844761 |
| August 6, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 676216 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
General Hearing Instruments Inc
FEI Number
2317393
Address
175 Brookhollow Esplanade, Harahan, Louisiana 70123, United States
Country
United States
ID: 9e77aa7a-0312-4038-b2fe-a4fe07fa7c8d