# FDA 483 - Sterigenics US, LLC - August 23, 2022

Source: https://www.keypedia.com/records/483/sterigenics-us-llc/7293bf61-b2d0-47bb-bda9-013c7a907b8d

> FDA 483 for Sterigenics US, LLC on August 23, 2022. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sterigenics US, LLC
- Inspection Date: 2022-08-23
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Sterigenics US, LLC in Fort Worth, TX, a contract sterilizer, was cited for significant quality system deficiencies during an FDA inspection. Observations included failing to record and justify deviations from test procedures, a quality control unit that did not timely complete investigations or close CAPAs, and a failure to follow procedures for handling customer complaints regarding drug products. These issues indicate a lack of adherence to established quality control and complaint handling processes.

## Related Documents

- [483 - 2022-08-23](https://www.keypedia.com/records/483/sterigenics-us-llc/c7d68552-7190-4c19-beaa-6b30ba91fd86)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [investigator](https://www.keypedia.com/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)
- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/sterigenics-us-llc/6d839594-4c70-40ab-85c7-7e1af043761e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab