# FDA 483 - Aptar France SAS - December 02, 2015

Source: https://www.keypedia.com/records/483/aptar-france-sas/09d86a22-7997-446b-815b-10356d6c10a5

> FDA 483 for Aptar France SAS on December 02, 2015. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aptar France SAS
- Inspection Date: 2015-12-02
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Aptar Pharma France, SAS, a testing laboratory in Le Vaudreuil, France, revealed significant deficiencies in laboratory controls. The firm was cited for inadequate verification of laboratory equipment, specifically balances, and for failing to properly investigate and trend laboratory incidents. These issues indicate a lack of robust quality control practices within the facility.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.keypedia.com/companies/aptar-france-sas/b349dbdb-c2c3-43dc-9511-f887c9a99ae5

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