# FDA 483 - Solvay USA Inc - November 13, 2015

Source: https://www.globalkeysolutions.net/records/483/solvay-usa-inc/37bcaf6c-1f4b-4ce4-b757-35b7e1f426b9

> FDA 483 for Solvay USA Inc on November 13, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Solvay USA Inc
- Inspection Date: 2015-11-13
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Solvay USA Inc. in Spartanburg, SC, a non-sterile API manufacturer, received an FDA Form 483 with eight observations following an inspection from November 9-13, 2015. The observations primarily concern failures in quality control, including inadequate testing of raw materials and process water, insufficient computerized system controls, and deficiencies in stability testing, batch record documentation, quality agreements, and procedures for expired products. These issues indicate a lack of robust quality management systems for the firm's API product, IGEPAL CO-630 Special USP - Pharmaceutical Grade.

## Related Officers

- [Director of Inspection Readiness](https://www.globalkeysolutions.net/people/bonita-s-chester/cc6ce6f4-bb5c-452a-820c-3339361bc8b2)
- [Jason K. Morgan](https://www.globalkeysolutions.net/people/jason-k-morgan/70f449a7-9e18-42a8-a88f-f9b536c31a5d)

Company: https://www.globalkeysolutions.net/companies/solvay-usa-inc/5e42cf0a-7fca-4de0-a3f2-e26790f44549

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7