# FDA 483 - Allergan Sales, LLC - October 08, 2015

Source: https://www.globalkeysolutions.net/records/483/allergan-sales-llc/e9b4bc9b-ce35-4ebf-8179-ff221959c3ee

> FDA 483 for Allergan Sales, LLC on October 08, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Sales, LLC
- Inspection Date: 2015-10-08
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Alcon Sales, LLC in Waco, TX, revealed significant deficiencies in their manufacturing processes for human drug products. The observations included inadequate stability programs, scientifically unsound laboratory controls, and failures in preventing microbiological contamination. Additionally, issues with personnel gowning and environmental monitoring in aseptic processing areas were noted, raising concerns about product quality and sterility.

## 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 - 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)
- [Diane Raccasi](https://www.globalkeysolutions.net/people/diane-raccasi/5c51bbf4-9c91-49c5-a1a5-d5aa7374890b)
- [Clinical Trials Associate](https://www.globalkeysolutions.net/people/rebeca-rodriguez/6dc44559-b1bf-44ac-95f3-af5fa8a4acd7)

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