FDA Inspection
Aptar France SASAptar France SAS – FDA Inspection, Feb 8, 2024
Record Details
This FDA Inspection record concerns Aptar France SAS, with an inspection on February 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4237e179-638c-494b-bcbb-588085d2d82b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229622
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Aptar France SAS
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 1, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 1, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aptar France SAS
- FDA Inspection 955098 - 2015-12-02
- FDA Inspection 674410 - 2010-07-01
- FDA Inspection 672898 - 2010-07-01
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