FDA Inspection
Amcor Flexibles, LLC.Amcor Flexibles, LLC. – FDA Inspection, May 2, 2013
Record Details
This FDA Inspection record concerns Amcor Flexibles, LLC., with an inspection on May 2, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amcor Flexibles, LLC.
- Inspection Date
- May 2, 2013
- Product Type
- Devices
View Company Profile
ID · d9a112a4-1be7-4e31-bb07-99b3da5323e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 832094
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Amcor Flexibles, LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Amcor Flexibles, LLC.
- FDA Inspection 1179530 - 2022-08-26
- FDA Inspection 1025286 - 2017-09-14
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