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

Source: https://www.globalkeysolutions.net/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

- [483 - 2015-06-22](https://www.globalkeysolutions.net/records/483/allergan-sales-llc/f79a54ac-fe57-4f0a-9220-80c8151e0115)
- [483 - 2015-07-10](https://www.globalkeysolutions.net/records/483/allergan-sales-llc/0505126c-fca5-4117-b3bd-11b1204606c2)
- [483 - 2015-10-08](https://www.globalkeysolutions.net/records/483/allergan-sales-llc/e9b4bc9b-ce35-4ebf-8179-ff221959c3ee)
- [483 - 2019-02-27](https://www.globalkeysolutions.net/records/483/allergan-sales-llc/209b505c-c846-4bd9-acbb-c413676c87f2)

## Related Officers

- [Ademola O. Daramola](https://www.globalkeysolutions.net/people/ademola-o-daramola/814113a4-38bc-4ce5-b6af-09c7e688c0ec)
- [Biologist at CBER](https://www.globalkeysolutions.net/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)

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

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