# FDA 483 - Allergan Industrie SAS - January 29, 2015

Source: https://www.globalkeysolutions.net/records/483/allergan-industrie-sas/094f5042-1c58-4e5d-ae56-c56ae8fe7839

> FDA 483 for Allergan Industrie SAS on January 29, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Industrie SAS
- Inspection Date: 2015-01-29
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Allergan Industrie SAS in Pringy, France, a medical device manufacturer, revealed significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to establish adequate procedures for identifying necessary actions to correct and prevent recurrence of nonconforming products. Additionally, procedures for verifying or validating the effectiveness of corrective and preventive actions were not adequately established, leading to ongoing product issues.

## Related Documents

- [483 - 2007-03-29](https://www.globalkeysolutions.net/records/483/allergan-industrie-sas/bd581f3e-2687-4a50-a121-fbf66931ae1f)

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.globalkeysolutions.net/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)

Company: https://www.globalkeysolutions.net/companies/allergan-industrie-sas/c48c669d-a3da-43da-8d93-624bf8799627

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd