# FDA 483 - Amcor Flexibles, LLC. - September 14, 2017

Source: https://www.keypedia.com/records/483/amcor-flexibles-llc/2b1a2514-c3c1-45fd-a28a-134d10f5224d

> FDA 483 for Amcor Flexibles, LLC. on September 14, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amcor Flexibles, LLC.
- Inspection Date: 2017-09-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Amcor Flexibles, a medical device manufacturer in Commerce, California, identified a significant quality system deficiency. The firm failed to adequately document the monitoring and verification of the effectiveness checks for its corrective and preventive actions (CAPA). This indicates a breakdown in ensuring the long-term efficacy of implemented quality improvements.

## Related Documents

- [483 - 2022-08-26](https://www.keypedia.com/records/483/amcor-flexibles-llc/8044baeb-3690-4f27-9b3c-9971789b9e76)

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/amcor-flexibles-llc/a987255c-32b8-4f02-a1e9-6b2aa50226b0

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6