# FDA 483 - Lambda Research, Inc. - August 26, 2022

Source: https://www.globalkeysolutions.net/records/483/lambda-research-inc/f00ab4c9-203e-40c2-918f-c275d79d8fac

> FDA 483 for Lambda Research, Inc. on August 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lambda Research, Inc.
- Inspection Date: 2022-08-26
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Lambda Research Inc, a control testing laboratory in Cincinnati, OH, revealed significant deficiencies in their quality control unit's procedures and documentation. The firm failed to adequately review and document periodic proficiency testing for laboratory personnel performing X-ray diffraction analysis of pharmaceutical samples. Additionally, the quality unit lacked written procedures outlining the scope and frequency of Current Good Manufacturing Practice (CGMP) training for relevant personnel.

## Related Officers

- [RafaeQ A Habash](https://www.globalkeysolutions.net/people/rafaeq-a-habash/c594bd13-9866-412d-984d-64a398aaf6b6)
- [Mathematical statistician](https://www.globalkeysolutions.net/people/wen-ning-chan/e1f71810-6994-4474-876f-699ea9dee32c)
- [Consumer Safety Officer , Investigator](https://www.globalkeysolutions.net/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.globalkeysolutions.net/companies/lambda-research-inc/3b078ecb-1e86-432c-9025-6184db7c8eb2

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22