FDA Inspection
Nalge Nunc International CorporationNalge Nunc International Corporation – FDA Inspection, Sep 26, 2018
Record Details
This FDA Inspection record concerns Nalge Nunc International Corporation, with an inspection on September 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9e05e993-ed3f-4269-97fa-c07129c3297a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067034
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Nalge Nunc International Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 5, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 15, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 7, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 27, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nalge Nunc International Corporation
- FDA Inspection 1226655 - 2024-01-05
- FDA Inspection 1159046 - 2021-12-15
- FDA Inspection 832570 - 2013-05-07
- FDA Inspection 649507 - 2010-04-27
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