# FDA 483 - Element Materials Technology Boston - Acton Inc. - May 04, 2026

Source: https://www.keypedia.com/records/483/element-materials-technology-boston-acton-inc/0f5f229c-dd3e-433f-ad08-ea8f8461e29f

> FDA 483 for Element Materials Technology Boston - Acton Inc. on May 04, 2026. 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: 2026-05-04
- Product Type: drugs
- Office Name: New England District Office
- Summary: Element Materials Technology Boston - Acton Inc., a contract testing laboratory in Acton, MA, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleanroom re-certification after HVAC maintenance, environmental monitoring program discrepancies, poor facility maintenance, and insufficient investigations into out-of-specification results. These issues indicate a lack of control over critical sterility testing processes and facility upkeep.

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## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

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