# FDA 483 - Allergan Sales, LLC - February 27, 2019

Source: https://www.globalkeysolutions.net/records/483/allergan-sales-llc/209b505c-c846-4bd9-acbb-c413676c87f2

> FDA 483 for Allergan Sales, LLC on February 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Sales, LLC
- Inspection Date: 2019-02-27
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Allergan Sales, LLC in Waco, TX, a sterile drug manufacturer, revealed three significant observations. The firm was cited for inadequate procedures to prevent microbiological contamination, deficiencies in environmental monitoring systems, and issues with cleaning and disinfection protocols in aseptic processing areas. These findings indicate potential risks to the sterility of drug products.

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## Related Officers

- [Principal Consultant](https://www.globalkeysolutions.net/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

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