# FDA 483 - DDP Specialty Electronic Materials US 9, LLC - November 07, 2018

Source: https://www.globalkeysolutions.net/records/483/ddp-specialty-electronic-materials-us-9-llc/63ecc9aa-fffb-4d4b-a047-cd3364fcceea

> FDA 483 for DDP Specialty Electronic Materials US 9, LLC on November 07, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DDP Specialty Electronic Materials US 9, LLC
- Inspection Date: 2018-11-07
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of DDP Specialty Electronic Materials U.S. 9, LLC in Hemlock, MI, an API manufacturer, revealed significant data integrity concerns. The firm failed to adequately review original laboratory records, including electronic raw data and audit trails, for accuracy and completeness. This deficiency impacts the quality determination of products like Simethicone USP.

## Related Documents

- [483 - 2018-11-07](https://www.globalkeysolutions.net/records/483/ddp-specialty-electronic-materials-us-9-llc/0ab15aad-3415-41cc-85e7-d6504389f0cd)

## Related Officers

- [Emily J. Orban](https://www.globalkeysolutions.net/people/emily-j-orban/e0008df4-4986-413d-a943-9fafcf385021)

Company: https://www.globalkeysolutions.net/companies/ddp-specialty-electronic-materials-us-9-llc/bfd7705b-0b03-4c4e-a3d7-d0940e04a868

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