EyePoint Pharmaceuticals, Inc.

Warning LetterOpen

Dr. Jay S. Duker President and Chief Executive Officer EyePoint Pharmaceuticals, Inc. 480 Pleasant St Ste B300 Watertown , MA 02472-2468 United StatesFEI 3005508657Issued Jul 12, 2024Office of Pharmaceutical Quality Operations Division I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005508657.

Violations4

Issue DateJul 12, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: EyePoint Pharmaceuticals, Inc.
Location: Dr. Jay S. Duker President and Chief Executive Officer EyePoint Pharmaceuticals, Inc. 480 Pleasant St Ste B300 Watertown , MA 02472-2468 United States
FEI Number: 3005508657
Country: United States
Issue Date: July 12, 2024
Issuing Office: Office of Pharmaceutical Quality Operations Division I
Product Type: Drugs
Status: Open

Summary

EyePoint Pharmaceuticals failed to maintain Current Good Manufacturing Practice (CGMP) standards for its drug manufacturing operations, rendering its drug products adulterated. During a February 2024 inspection, investigators identified significant violations including the company's failure to thoroughly investigate unexplained discrepancies and failures in batch specifications, such as an atypical high release rate value for YUTIQ (fluocinolone acetonide intravitreal implant) that was not properly investigated for root cause or preventative actions. The company did not conduct timely investigations to ensure other potentially affected batches were identified, creating systemic compliance deficiencies in their quality control and batch investigation procedures.

EyePoint Pharmaceuticals, Inc. FDA Warning Letter, July 12, 2024