# FDA 483 - Alcon Research LLC - July 24, 2014

Source: https://www.globalkeysolutions.net/records/483/alcon-research-llc/a7ccd724-f829-4244-b454-4e44602ca9c4

> FDA 483 for Alcon Research LLC on July 24, 2014. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcon Research LLC
- Inspection Date: 2014-07-24
- Product Type: other
- Office Name: Dallas District Office
- Summary: Alcon Research, Ltd. in Fort Worth, TX, a non-clinical laboratory, was inspected by the FDA. The inspection revealed significant deficiencies related to standard operating procedures for animal care, including inadequate monitoring for yeast/mold and unperformed quality control. Additionally, issues were noted with data integrity concerning lot number discrepancies and a lack of established procedures for documenting the receipt and final disposition of test and control articles.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/joel-martinez/c83d1413-732e-4d56-b4d1-672705413a18)

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