# FDA 483 - Interquim S.A. - September 27, 2019

Source: https://www.globalkeysolutions.net/records/483/interquim-sa/924924b5-baa0-4054-9388-1fb22dcced93

> FDA 483 for Interquim S.A. on September 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Interquim S.A.
- Inspection Date: 2019-09-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Interquim S.A., an API manufacturer, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to thoroughly investigate unexplained discrepancies in intermediate and finished-API testing and did not obtain quality unit approval for deviations from approved protocols during method validation. These issues highlight a lack of robust quality management system practices.

## Related Officers

- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/interquim-sa/97e3ab74-e2ba-4b9a-8932-8b7e15c0d511

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6