# FDA 483 - Allergan Sales, LLC - October 28, 2016

Source: https://www.keypedia.com/records/483/allergan-sales-llc/e3c1349c-5578-4f6c-b329-fbee3723c6f6

> FDA 483 for Allergan Sales, LLC on October 28, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Sales, LLC
- Inspection Date: 2016-10-28
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Allergan Sales, LLC in Waco, TX, revealed significant deficiencies across multiple systems, including incomplete laboratory records, inadequate data controls, and a failure to thoroughly investigate batch failures. The firm also exhibited issues with aseptic processing areas, persistent manufacturing problems leading to underfilled vials and particulates, and a lack of control over electronic systems and sampling procedures. These findings indicate a systemic lack of oversight and control over critical manufacturing and quality processes for sterile ophthalmic drug products.

## Related Documents

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- [EIR - 2009-03-20](https://www.keypedia.com/records/eir/allergan-sales-llc/658fe90c-22d6-48b4-8643-bd4f0072e491)

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Company: https://www.keypedia.com/companies/allergan-sales-llc/dced41da-32c6-41b1-829c-6287550c2c71

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9