FDA sends warning letters to eye implant, bone matrix manufacturers

In two recent actions, the US Food and Drug Administration (FDA) issued warning letters to an eye implant manufacturer for a multitude of good manufacturing practice (GMP) violations and a biologics manufacturer for marketing unapproved bone matrix products. Both letters were posted on FDA’s website on 27 August.

In a 12 July warning letter to EyePoint Pharmaceuticals, FDA chastised the company for several issues tied to its eye implant Yutiq (fluocinolone acetonide intravitreal implants) following an inspection of the company’s facility in Watertown, MA last February. The implant is intended to be placed in the eye to treat chronic non-infectious uveitis; Alimera Sciences acquired the commercial rights to Yutiq in May 2023.

The company was criticized for failing to investigate “atypically high release rates” for Yutiq’s drug core, which was the subject of two complaints that stated the product failed to achieve its desired therapeutic effect.

The company also failed to keep its facility in good repair; investigators found three leaks in the roof, which resulted in moisture ingress in its environmentally controlled manufacturing areas. The firm did not identify any long-term prevention actions, even though the leaks had been occurring since July 2023.

Investigators also said the company did not investigate batch failures promptly. While an out of specification investigation (OOS) into a batch failure was launched in October 2023, the investigation remained open for four months, until February 2024, despite a December 2023 deadline.

While the affected batch remained in quarantine, the company continued to manufacture and release additional batches without completing the investigation and determining whether other batches were affected with the specific deficiency.

FDA said EyePoint also failed to conduct tests demonstrating that its manufacturing processes were in a state of control, including process performance studies demonstrating blend uniformity. The company also did not generate statistical process control charts to monitor manufacturing performance as required by its procedures.

The firm has 15 days to correct the violations in the warning letter.

Berkeley Biologics cited for making unapproved bone matrix products

FDA also warned Richmond, CA-based Berkeley Biologics for marketing viable bone matrix products derived from bone tissue without a proper marketing approval. The company was also chastised for multiple GMP and good tissue practice (GTP) violations. The warning letter concerns several of the company’s products, the Viable Bone Matrix (VBM), Fiber Viable Bone Matrix (FVBM), Cellular Fiber Matrix (CFM)/Excel Viable Bone Matrix (EFM), and Osteo Viable Bone Matrix (OVM).

These products are distributed throughout the US to medical facilities and used for orthopedic or reconstructive bone grafting procedures for bone repair and regeneration and are purportedly sterile.

FDA said that company’s products do not meet the exception criteria for HCT/Ps laid out in 21 CFR 1271.10(a) and the criteria under 21 CFR 1271.15, and thus do not qualify for regulation solely under section 361 of the Public Health Service Act and instead are regulated under the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act.

Investigators also found several GMP violations, including lax systems for monitoring or preventing contamination.

The company was also reprimanded for deficient donor screening procedures under GTPs. The company “failed to determine as ineligible (b)(4) deceased donors who have a documented medical diagnosis of sepsis … Tissues from these donors were manufactured into FVBM and OVM, and distributed for implantation into patients/recipients, some of which were associated with an outbreak of Mycobacterium tuberculosis infections,” said the letter.

The company has 15 days to respond to the warning letter.

EyePoint Pharmaceuticals, Berkeley Biologics

FDA sends warning letters to eye implant, bone matrix manufacturers

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