# FDA 483 - Aptar Stelmi SA - May 10, 2016

Source: https://www.globalkeysolutions.net/records/483/aptar-stelmi-sa/675b9ae5-b771-4b41-ae0c-8bbfbb90b554

> FDA 483 for Aptar Stelmi SA on May 10, 2016. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aptar Stelmi SA
- Inspection Date: 2016-05-10
- Product Type: other
- Office Name: International Compliance Team
- Summary: An FDA inspection of Stelmi SA, a component sterilizer in Granville, France, revealed a significant quality system deficiency. The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification results for metal particulates and bioburden, indicating a lack of robust root cause analysis. This could impact the quality and safety of sterilized components.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/aptar-stelmi-sa/d6a280c5-17d6-4569-b621-fee9f3e9fa87

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321