# FDA 483 - Alcon Research LLC - August 30, 2024

Source: https://www.globalkeysolutions.net/records/483/alcon-research-llc/fb7747ef-07ac-4476-9bf0-e5adc0cdef0f

> FDA 483 for Alcon Research LLC on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcon Research LLC
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Alcon Research LLC, a sterile drug manufacturer in Fort Worth, TX, received a Form 483 with three observations. The inspection revealed deficiencies in facility maintenance, including structural damage and rust, as well as inadequate laboratory controls for sterility testing. Additionally, the firm lacked sufficient systems and processes to comply with Drug Supply Chain Security Act (DSCSA) verification and recordkeeping requirements.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)
- [Investigator](https://www.globalkeysolutions.net/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)
- [Daphne N Purdy](https://www.globalkeysolutions.net/people/daphne-n-purdy/fbce86a8-295f-44df-91f9-c0aee8fe2801)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab