# FDA 483 - Sterigenics US, LLC - May 04, 2023

Source: https://www.keypedia.com/records/483/sterigenics-us-llc/55237e4d-5871-4919-bf06-ba2371f4fdb1

> FDA 483 for Sterigenics US, LLC on May 04, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sterigenics US, LLC
- Inspection Date: 2023-05-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Sterigenics US, LLC, a contract gamma sterilizer in West Memphis, AR, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive actions for spectrophotometer test failures and did not evaluate the impact of out-of-specification test equipment on device quality. Additionally, Sterigenics lacked written Medical Device Reporting (MDR) procedures.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)
- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.keypedia.com/companies/sterigenics-us-llc/19ca262f-f171-4463-bc45-30afa40febcd

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