# FDA 483 - Amcor Flexibles, LLC. - August 26, 2022

Source: https://www.globalkeysolutions.net/records/483/amcor-flexibles-llc/8044baeb-3690-4f27-9b3c-9971789b9e76

> FDA 483 for Amcor Flexibles, LLC. on August 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amcor Flexibles, LLC.
- Inspection Date: 2022-08-26
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Amcor Flexibles, LLC., a medical device manufacturer in Commerce, CA, revealed three significant observations. The firm was cited for inadequate procedures to control non-conforming product, sampling plans not based on valid statistical rationale, and poorly established schedules for equipment maintenance. These issues indicate deficiencies in the firm's quality system.

## Related Documents

- [483 - 2017-09-14](https://www.globalkeysolutions.net/records/483/amcor-flexibles-llc/2b1a2514-c3c1-45fd-a28a-134d10f5224d)

## Related Officers

- [Sarah Hasias](https://www.globalkeysolutions.net/people/sarah-hasias/47194752-32b7-4874-a703-ca33a2485123)

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

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