FDA Inspection
Amcor Rigid Packaging USA, LLCAmcor Rigid Packaging USA, LLC – FDA Inspection, Jan 12, 2023
Record Details
This FDA Inspection record concerns Amcor Rigid Packaging USA, LLC, with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ba629b71-c1ef-4280-8ba2-925cd7d8ded4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1194959
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Amcor Rigid Packaging USA, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2025 | NAI | Dallas District Office | Postmarket Assurance: Medical Devices |
| November 15, 2018 | Not classified | Dallas District Office |
Other documents for Amcor Rigid Packaging USA, LLC
- FDA Inspection 1275371 - 2025-07-11
- FDA Inspection 1073521 - 2018-11-15
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