FDA Inspection
Gibson Laboratories, LLCGibson Laboratories, LLC – FDA Inspection, Sep 14, 2009
Record Details
This FDA Inspection record concerns Gibson Laboratories, LLC, with an inspection on September 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gibson Laboratories, LLC
- Inspection Date
- September 14, 2009
- Product Type
- Devices
View Company Profile
ID · ded5a5ae-4756-4337-9bd9-fcab4d6d70e3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 610286
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Gibson Laboratories, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 3, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 2, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 12, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 29, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gibson Laboratories, LLC
- FDA Inspection 1238338 - 2024-04-25
- FDA Inspection 1165243 - 2022-03-03
- FDA Inspection 1035086 - 2017-11-02
- FDA Inspection 859677 - 2013-12-12
- FDA Inspection 659193 - 2010-04-29
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