# FDA 483 - Allergan Sales, LLC - July 10, 2015

Source: https://www.globalkeysolutions.net/records/483/allergan-sales-llc/0505126c-fca5-4117-b3bd-11b1204606c2

> FDA 483 for Allergan Sales, LLC on July 10, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Sales, LLC
- Inspection Date: 2015-07-10
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Allergan Sales, LLC in Waco, TX, revealed significant deficiencies in their quality system, particularly concerning the thoroughness and timeliness of investigations into product complaints and environmental control issues. The firm also failed to follow aseptic cleaning procedures for sterile ophthalmic product filling lines. These issues indicate a lack of robust quality oversight and potential risks to product quality and patient safety.

## Related Documents

- [483 - 2015-06-22](https://www.globalkeysolutions.net/records/483/allergan-sales-llc/f79a54ac-fe57-4f0a-9220-80c8151e0115)
- [483 - 2015-10-08](https://www.globalkeysolutions.net/records/483/allergan-sales-llc/e9b4bc9b-ce35-4ebf-8179-ff221959c3ee)
- [483 - 2016-10-28](https://www.globalkeysolutions.net/records/483/allergan-sales-llc/e3c1349c-5578-4f6c-b329-fbee3723c6f6)
- [483 - 2019-02-27](https://www.globalkeysolutions.net/records/483/allergan-sales-llc/209b505c-c846-4bd9-acbb-c413676c87f2)

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.globalkeysolutions.net/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [Investigator](https://www.globalkeysolutions.net/people/shelby-n-marler/2cbb1b1c-ad36-4385-b61f-bee80ad8e1bd)
- [Clinical Trials Associate](https://www.globalkeysolutions.net/people/rebeca-rodriguez/6dc44559-b1bf-44ac-95f3-af5fa8a4acd7)
- [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