# FDA 483 - Allergan Sales, LLC - November 07, 2025

Source: https://www.keypedia.com/records/483/allergan-sales-llc/22954531-e534-441b-863f-bbedcbf15b17

> FDA 483 for Allergan Sales, LLC on November 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Sales, LLC
- Inspection Date: 2025-11-07
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Allergan Sales, LLC (BLI) in Irvine, CA, was cited for significant deficiencies in its drug substance manufacturing processes, particularly concerning contamination control and environmental monitoring. The inspection revealed inadequate process design, insufficient microbial control strategies, and flawed risk assessments, indicating a lack of assurance in maintaining drug substance quality and preventing contamination.

## Related Documents

- [483 - 2010-07-09](https://www.keypedia.com/records/483/allergan-sales-llc/dc2754a0-383b-4aca-b94a-0cc7b5d6a4cb)
- [483 - 2025-11-07](https://www.keypedia.com/records/483/allergan-sales-llc/12dec849-c2f0-4857-995e-202ccb5ee45b)

## Related Officers

- [Joao Pedras-Vasconcelos](https://www.keypedia.com/people/joao-pedras-vasconcelos/143cf25e-168d-43da-adc8-9107c4f01b44)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/priscilla-amaral/40f8110f-e324-4583-b97c-4daacad0e299)
- [Md Kamal Hossain](https://www.keypedia.com/people/md-kamal-hossain/843966c9-de35-486c-99af-bddfb1256374)
- [Joao A. Pedras Vasconcel](https://www.keypedia.com/people/joao-a-pedras-vasconcel/9fa800c2-e305-4f9b-8cee-ada48d969faa)
- [Priscilla Amador Do Amaral](https://www.keypedia.com/people/priscilla-amador-do-amaral/aaa92850-10d1-4b87-a13e-7c4cf3cd00da)

Company: https://www.keypedia.com/companies/allergan-sales-llc/1c953156-6298-4351-8d2d-bc0fa979d4eb

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b