# FDA 483 - Element Materials Technology Ann Arbor, LLC - September 09, 2022

Source: https://www.keypedia.com/records/483/element-materials-technology-ann-arbor-llc/b9a4a39b-0373-4740-ad36-4ea20d15d34e

> FDA 483 for Element Materials Technology Ann Arbor, LLC on September 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Element Materials Technology Ann Arbor, LLC
- Inspection Date: 2022-09-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: This FDA Form 483 report details significant deficiencies at Element Materials Technology Ann Arbor, LLC, a contract testing laboratory. The inspection revealed critical issues with data integrity, including inadequate controls over computer systems, lack of audit trail review, and non-attributable electronic records. Additionally, the firm's quality control unit failed to routinely review instrument logbooks for stability chambers, indicating a lapse in quality oversight.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Investigator](https://www.keypedia.com/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)

Company: https://www.keypedia.com/companies/element-materials-technology-ann-arbor-llc/84b936d0-5231-4925-b094-8515ab19bdcf

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0