# FDA 483 - Alcon Research LLC - August 04, 2017

Source: https://www.globalkeysolutions.net/records/483/alcon-research-llc/fede0aaf-645b-42cd-bef8-ae02246e2673

> FDA 483 for Alcon Research LLC on August 04, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcon Research LLC
- Inspection Date: 2017-08-04
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Alcon Research, Ltd. in Fort Worth, TX, a sterile drug/device manufacturer, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in procedures designed to prevent microbiological contamination of sterile drug products, including inadequate SOPs for HEPA transfer carts and issues with personnel monitoring. Additionally, the firm failed to establish appropriate finished product release and shelf-life specifications for degradants/impurities for a drug product.

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## Related Officers

- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)
- [Development Coordinator](https://www.globalkeysolutions.net/people/shawn-e-larson/a3515e47-60a3-48ff-b27c-f79bd03db12b)

Company: https://www.globalkeysolutions.net/companies/alcon-research-llc/6d858925-5b89-47d3-a993-71eec446f320

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9