# FDA 483 - Sandoz Incorporated - April 16, 2019

Source: https://www.globalkeysolutions.net/records/483/sandoz-incorporated/afbe4c62-da17-4bdc-a1ca-e2ca1b463f6f

> FDA 483 for Sandoz Incorporated on April 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz Incorporated
- Inspection Date: 2019-04-16
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Sandoz Incorporated in Broomfield, CO, revealed significant deficiencies in their drug manufacturing operations. The firm failed to thoroughly investigate unexplained discrepancies, including metallic particle contamination in drug products and out-of-specification water samples, without adequate health hazard assessments. Additionally, laboratory control mechanisms and system suitability failures were not properly reviewed by Quality Assurance, and packaging equipment was found to be poorly maintained, posing a risk of foreign material contamination.

## Related Documents

- [483 - 2011-05-06](https://www.globalkeysolutions.net/records/483/sandoz-incorporated/baaabca0-2926-45dd-a2f6-0907f5119191)

## Related Officers

- [Compliance Officer / Investigator](https://www.globalkeysolutions.net/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.globalkeysolutions.net/companies/sandoz-incorporated/6aa8ae0e-b0f0-49a7-a584-c6e6796c6481

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face