# FDA 483 - EyePoint Pharmaceuticals, Inc. - August 28, 2019

Source: https://www.globalkeysolutions.net/records/483/eyepoint-pharmaceuticals-inc/8682ee17-ffa8-4d02-b73e-0088759e15d8

> FDA 483 for EyePoint Pharmaceuticals, Inc. on August 28, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EyePoint Pharmaceuticals, Inc.
- Inspection Date: 2019-08-28
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: EyePoint Pharmaceuticals, Inc. in Watertown, MA, was cited for significant deficiencies across its manufacturing operations, particularly concerning quality control, investigations, and aseptic processing. The inspection revealed failures in investigating product complaints, out-of-specification results, and environmental monitoring excursions, alongside issues with data integrity in computer systems and inadequate maintenance of cleanroom conditions. The firm also demonstrated poor control over stability studies, equipment calibration, cleaning procedures, and supplier qualification for critical components.

## Related Documents

- [483 - 2024-02-15](https://www.globalkeysolutions.net/records/483/eyepoint-pharmaceuticals-inc/cc3c2031-e2c5-4a29-a1dd-f81d0eec76e4)
- [WARNING_LETTER - 2024-02-15](https://www.globalkeysolutions.net/records/warning_letter/eyepoint-pharmaceuticals-inc/e379cc88-9b93-49f9-897d-71e0ceb96159)

## Related Officers

- [Chhaya Shetty](https://www.globalkeysolutions.net/people/chhaya-shetty/e06ed3c2-5db9-4689-a4a4-a71efa4b2c7c)
- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7