# FDA 483 - Burpee Materials Technology, LLC - August 08, 2023

Source: https://www.keypedia.com/records/483/burpee-materials-technology-llc/8e0300b1-0da9-4494-bae5-9f8c302d2adb

> FDA 483 for Burpee Materials Technology, LLC on August 08, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Burpee Materials Technology, LLC
- Inspection Date: 2023-08-08
- Product Type: other
- Office Name: New Jersey District Office
- Summary: Burpee Materials Technology, LLC, a contract manufacturer in Eatontown, NJ, was cited for inadequate documentation of corrective and preventive action activities. The inspection revealed failures to document non-conforming events, including out-of-specification cleanroom particulate results and a missed sterilization process assessment, as required by their internal procedures. This indicates a significant issue with their quality system's handling of non-conformities and CAPA inputs.

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.keypedia.com/companies/burpee-materials-technology-llc/593e6bdd-f4aa-4de4-9bd6-98173cfd3d11

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248