FDA Inspection
Klockner Of North AmericaKlockner Of North America – FDA Inspection, Oct 28, 2016
Record Details
This FDA Inspection record concerns Klockner Of North America, with an inspection on October 28, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 28f899ab-02be-40f6-8988-d78d36a943e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996793
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Klockner Of North America
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 27, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Klockner Of North America
- FDA Inspection 1247485 - 2024-08-21
- FDA Inspection 1081204 - 2019-02-27
- FDA Inspection 802887 - 2012-10-03
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