Company
United StatesGibson Laboratories, LLC, Lexington, KY – FDA Inspections
Inspection records and compliance data for Gibson Laboratories, LLC in Lexington, Kentucky. 6 FDA inspections on record (1 OAI), last inspected April 25, 2024.
Company Profile
This profile covers Gibson Laboratories, LLC based in Lexington, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected September 14, 2009. Last inspected April 25, 2024.
Most cited issue areas
- Identification of actions needed1 inspection
- Investigation1 inspection
- Lack of or inadequate procedures for handling1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 25, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1238338 |
| March 3, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1165243 |
| November 2, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1035086 |
| December 12, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 859677 |
| April 29, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 659193 |
| September 14, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 610286 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gibson Laboratories, LLC
FEI Number
1050138
Address
1040 Manchester St, Lexington, Kentucky 40508, United States
Country
United States
ID: 5d4551fe-a24b-40ed-b9fa-ce785ad6538c