USFDA Warning Letter to Catalent Indiana Following OAI Classification

The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent Indiana sterile drug products facility (FEI 3005949964) with a Warning letter.  Earlier, the USFDA 483 issued after inspection of the Bloomington, Indiana site had cited critical deviations and customer complaints of mammalian hair contamination in drug product vials and inadequate investigations into quality events. The site was inspected by USFDA investigators Joohi Castelvetere, Robert J.Ham, Martin M.Kimani and Shannon L.Maisano in June–July 2025.

The warning letter highlighted lapses in investigation into mammalian hair contamination, customer complaints, incoming inspection, termination of media fills, contamination hazards.

Lapses in Investigations

The Warning Letter highlighted that Catalent’s investigations into drug product failures and discrepancies were inadequate – lacked root causes supported with data, verification of CAPA effectiveness and impact analysis were limited in scope.

Mammalian Hair Contamination

The Firm logged more than 20 incidents of mammalian hair around the stoppers of drug product vials since 2023. Mammalian hair is an extrinsic particle, indicate potential microbial contamination and render product adulterated. But the investigations and trend evaluations were not thorough, were narrow in scope and timeframe. Quality unit (QU) did not reject the batches with hair contamination and released the batches after attempting to cull out contaminated vials. And the Firm continued to receive complaints from customers on contamination.

Deficient Incoming Inspection of Stoppers

Catalent attributed contamination to supplier of stoppers, but continued to receive stoppers from the supplier with a preshipment sample inspection program for incoming inspection. But FDA noted that heightened testing with a specialized protocol offers only minimal short-term assurance unless supplier remediate mammalian hair contamination risks. Also even while sampling oversight was increased for the supplier, it did not extend it for other suppliers. FDA also objected to reliance on preshipment or tailgate samples, reminding that quality testing must be performed on samples taken from containers received at the site.

Terminated Media Fills Without Justification

Multiple media fill batches were terminated and re-executed for reasons including stoppering issues and extrinsic particles. No deviations were logged, nor investigations initiated, despite SOP requirements. FDA did not accept Firm’s claim of “no impact to SISPQ (Safety, Identity, Strength, Purity, Quality)”. The warning letter flagged that no investigations, root cause, justifications for aborting the media fills or corrective actions were provided and failure to initiate deviations resulted in undercounting of deviations.

Contamination Control Deficiencies

Visual Inspection: Defects were trended only by broad categories (critical, major, minor), not by individual defect types such as hair, glass, or atypical particulates.

Contamination Hazards: Equipment surfaces were occluded during atypical interventions / or due to wrapping, reducing exposure and decontamination effectiveness and led to environment monitoring failures. Also sampling by contact plate for post-filling environmental monitoring activities is not able to attribute contamination events to specific sources. FDA highlighted that use of contact plate for sampling is not as effective as swab methods and increase risk of failing to detect microbial contaminants for product contacting and irregular surfaces.

Comprehensive and Independent Review of Investigation systems

The Warning Letter requires Catalent to provide a comprehensive and independent review of its investigation systems, with emphasis on:

• Retrospective review of all complaints.
• Assessment of vials rejected for extrinsic particles.
• Investigations into mammalian hair contamination.
• Media fill terminations.

The CAPA plans should include enhanced operations management oversight, prompt detection of equipment / facility issues, preventive maintenance and technological upgrades and strengthened systems for management review.

FDA has also asked Catalent for a comprehensive remediation plan covering:

• Risk assessment of all contamination hazards.
• Expanded incoming inspection of stoppers across all suppliers.
• Heightened acceptable quality limits for reinspection after defect identification.
• Swab sampling for environmental monitoring and results
• Review and identification of locations that are not reliably exposed to decontamination and plan to reduce occluded surfaces
• Review of all permitted interventions and elimination / redesign of high-risk interventions that poses unacceptable contamination risks.

• USFDA Warning Letter to Catalent Indiana LLC (November 2025)

Related Posts:

• FDA 483 to Catalent Indiana Flags Inadequate Investigation of Contaminants, Equipment Failure – Qvents
• FDA Classifies Novo Nordisk Plant OAI, Product Approval for Regeneron, Scholar Rock Stuck – Qvents