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# Incyte Gets ‘Complete Response’ Over Catalent Inspection Issues
- URL: https://www.fdaweb.com/incyte-gets-complete-response-over-catalent-inspection-issues/
- Published: 2026-03-09T12:00:00.000Z
- Updated: 2026-09-14T13:35:07.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160781

FDA has issued Incyte a complete response letter (CRL) for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection (375mg) for an additional indication for treating adult patients with metastatic non-small cell lung cancer in combination with platinum-based chemotherapy. The sBLA was based on data from the Phase 3 POD1UM-304 trial.

The agency letter cited inspection findings (not specific to Zynyz) at Catalent Indiana, part of Novo Nordisk, the third-party fill-finish facility referenced in the sBLA. It cited the regulatory compliance of Catalent Indiana as the sole approvability issue, and did not cite other approvability concerns, including Zynyz’s efficacy and safety data or the third-party drug substance manufacturer, according to the company.

Incyte says it is working closely with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission.

The Catalent facility was hit last year with a [Warning Letter](https://fdaweb.com/login.php?sa=v&aid=D5160398&cate=&stid=%241%242I0.hf0.%245cFRPnP.EvSG3am0a8GLi%2F&ref=fdaweb.com) that cited significant violations of current good manufacturing practice (CGMP) regulations after investigators found repeated failures to properly investigate contamination events and aseptic processing risks.

The facility, which was acquired by Novo Nordisk in 12/2024, has a history of CGMP compliance troubles. Most recently, FDA assigned an “Official Action Indicated” classification to a July inspection ([see story](https://fdaweb.com/login.php?sa=v&aid=D5160032&cate=&stid=%241%24t%2F..y42.%24cbaogaRYJw21UfIT5%2Fb1V0&ref=fdaweb.com)) that revealed significant CGMP deficiencies. The serious compliance designation has delayed the approval and production timelines for drug products, including those from partner companies Regeneron and Scholar Rock, which are made at the plant.

The Warning Letter followed an FDA inspection conducted 6/23 to 7/14/2025 at the facility, which produces sterile injectable drugs for multiple customers. FDA said deficiencies in Catalent’s manufacturing controls rendered drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

A central concern outlined in the letter involved widespread contamination of finished drug products with extrinsic “mammalian hair,” an issue FDA said the company failed to adequately investigate, trend, or remediate over an extended period.

According to the agency, Catalent identified more than 20 deviations beginning in August 2023 related to mammalian hair found in or around vial stopper regions, including instances where hair was in direct contact with drug product. The events affected nearly \[(b)(4) REDACTED\] batches across at least \[(b)(4) REDACTED\] drug products for multiple customers, it said.

Additionally, FDA said Catalent did not initiate timely investigations, failed to recognize contamination trends, and inadequately implemented corrective and preventive actions with stopper suppliers. Despite attempts to remove contaminated units through visual inspection, the firm released affected commercial batches for distribution, and customers later reported finding mammalian hair in received products.