# FDA 483 - Aldrich Chemical Co. LLC - June 20, 2016

Source: https://www.globalkeysolutions.net/records/483/aldrich-chemical-co-llc/986f5497-40bf-4bb9-b845-97520952ab85

> FDA 483 for Aldrich Chemical Co. LLC on June 20, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aldrich Chemical Co. LLC
- Inspection Date: 2016-06-20
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Aldrich Chemical Co. LLC, an API manufacturer in Miami Township, Ohio, was cited for significant data integrity deficiencies during an FDA inspection. The firm failed to establish adequate controls to prevent the alteration or deletion of electronic raw data from an analytical instrument used for residual solvent analysis. This included issues with employee access, unauthorized computer access, and a lack of written procedures for data control and backup.

## Related Officers

- [Jennifer L Gustavus, Investigator](https://www.globalkeysolutions.net/people/jennifer-l-gustavus-investigator/480fbcf7-7ce3-4887-ac7d-c102735d80f4)

Company: https://www.globalkeysolutions.net/companies/aldrich-chemical-co-llc/b7c49225-a25e-440d-8d85-aca07e65a9b5

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