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

Source: https://www.keypedia.com/records/warning_letter/eyepoint-pharmaceuticals-inc/e379cc88-9b93-49f9-897d-71e0ceb96159

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: EyePoint Pharmaceuticals, Inc.
- Inspection Date: 2024-02-15
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality Operations Division I
- Summary: The FDA issued a Warning Letter to EyePoint Pharmaceuticals, Inc. following an inspection from February 6-15, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for their combination drug product, YUTIQ. The drug product is deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate unexplained discrepancies, identify root causes, implement appropriate preventative actions, and conduct timely investigations. Examples include an uninvestigated atypical release rate for YUTIQ batch 2022-00008 (linked to product complaints), lack of long-term preventative actions for roof leaks, and delayed investigation for YUTIQ batch 2023-00008's failed release rate. The firm's response was inadequate, lacking scientific justification for proposed specifications and commitment to investigate all affected batches.
2. **Inadequate Production and Process Controls (21 CFR 211.100(a) and 211.100(b)):** Lack of adequate scientific procedures to assure drug product identity, strength, quality, and purity. Deficiencies included insufficient process performance studies for blend uniformity, operation of manufacturing machines at lower-than-required air pressures, failure to generate statistical process

## Related Documents

- [483 - 2019-08-28](https://www.keypedia.com/records/483/eyepoint-pharmaceuticals-inc/8682ee17-ffa8-4d02-b73e-0088759e15d8)
- [483 - 2024-02-15](https://www.keypedia.com/records/483/eyepoint-pharmaceuticals-inc/cc3c2031-e2c5-4a29-a1dd-f81d0eec76e4)

## Related Officers

- [Samina S. Khan](https://www.keypedia.com/people/samina-s-khan/ca3e266c-aa69-4c28-9901-d344e0c259fd)
- [Program Division Director](https://www.keypedia.com/people/lisa-m-harlan/e5d04349-6dd6-4f08-b31f-bf719c8413ab)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations-division-i/798d6a62-d1f1-4f7c-8de3-465e277c13da