Company
United StatesThe Hygenic Company LLC., Akron, OH – FDA Inspections
Inspection records and compliance data for The Hygenic Company LLC. in Akron, Ohio. 3 FDA inspections on record, 1 Form 483, last inspected December 17, 2021.
Company Profile
This profile covers The Hygenic Company LLC. based in Akron, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 20, 2012. Last inspected December 17, 2021.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Lack of or inadequate process validation1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 17, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1161392 |
| June 29, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1016174 |
| January 20, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 764076 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
The Hygenic Company LLC.
FEI Number
1519375
Address
1245 Home Ave, Akron, Ohio 44310, United States
Country
United States
ID: 28efd539-c597-4c73-839e-9ac2ae688bed