# FDA 483 - Element Materials Technology Boston - Acton Inc. - August 01, 2025

Source: https://www.keypedia.com/records/483/element-materials-technology-boston-acton-inc/dbe185a8-bf2e-4522-a8b1-a98b6ec9f219

> FDA 483 for Element Materials Technology Boston - Acton Inc. on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Element Materials Technology Boston - Acton Inc.
- Inspection Date: 2025-08-01
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Element Materials Technology Boston - Acton, Inc. revealed significant deficiencies in its quality control unit and equipment logging practices. The firm failed to properly investigate environmental monitoring excursions and out-of-specification results, and its raw material control system was inadequate. Additionally, critical equipment logs for endotoxin testing lacked essential batch processing details, indicating a need for improved record-keeping and quality oversight.

## Related Documents

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## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)

Company: https://www.keypedia.com/companies/element-materials-technology-boston-acton-inc/24258d5a-8309-4e67-90f1-adda6124441c

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144