# Allergan Sales, LLC – FDA 483, Oct 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

- 483 - 2026-07-31 — date: July 31, 2026
- [EIR - 2019-06-06](https://www.keypedia.com/records/eir/allergan-sales-llc/d360b2ce-7ce0-4165-ab98-7daecc70433a) — date: June 6, 2019
- [483 - 2019-02-27](https://www.keypedia.com/records/483/allergan-sales-llc/209b505c-c846-4bd9-acbb-c413676c87f2) — date: February 27, 2019
- [EIR - 2019-02-27](https://www.keypedia.com/records/eir/allergan-sales-llc/093578ba-d845-4cf3-9593-cb92ccc6efe2) — date: February 27, 2019
- [EIR - 2016-10-28](https://www.keypedia.com/records/eir/allergan-sales-llc/1382c9d4-32f9-47d6-bc67-cfce19c2119a) — date: October 28, 2016

## Related Officers

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

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