FDA Inspection
Klockner Of North AmericaKlockner Of North America – FDA Inspection, Feb 27, 2019
Record Details
This FDA Inspection record concerns Klockner Of North America, with an inspection on February 27, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f52801bb-2708-44ac-98b3-e0aa21e2a229
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1081204
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.260(e)Periodic review of temperatures
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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 |
| October 28, 2016 | 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 996793 - 2016-10-28
- FDA Inspection 802887 - 2012-10-03
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