# FDA 483 - EyePoint Pharmaceuticals, Inc. - February 15, 2024

Source: https://www.globalkeysolutions.net/records/483/eyepoint-pharmaceuticals-inc/cc3c2031-e2c5-4a29-a1dd-f81d0eec76e4

> FDA 483 for EyePoint Pharmaceuticals, Inc. on February 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EyePoint Pharmaceuticals, Inc.
- Inspection Date: 2024-02-15
- Product Type: drugs
- Office Name: New England District Office
- Summary: EyePoint Pharmaceuticals, Inc. in Watertown, MA, was inspected by the FDA from February 6-15, 2024, resulting in seven observations, many of which were repeat findings. The inspection revealed significant deficiencies in quality control, manufacturing process validation, aseptic processing, and documentation practices. These issues raise concerns about the consistency, sterility, and overall quality of their YUTIQ 0.18 mg drug product.

## Related Documents

- [483 - 2019-08-28](https://www.globalkeysolutions.net/records/483/eyepoint-pharmaceuticals-inc/8682ee17-ffa8-4d02-b73e-0088759e15d8)
- [WARNING_LETTER - 2024-02-15](https://www.globalkeysolutions.net/records/warning_letter/eyepoint-pharmaceuticals-inc/e379cc88-9b93-49f9-897d-71e0ceb96159)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Armen H. Youssoufian](https://www.globalkeysolutions.net/people/armen-h-youssoufian/47aa0283-ca67-4aec-8ac1-7d4cb222eb04)
- [M.S., Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

Company: https://www.globalkeysolutions.net/companies/eyepoint-pharmaceuticals-inc/ca6562a2-b315-4e33-b9b2-394c1c8ad945

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144