FDA Warns Catalent Indiana for CGMP Lapses
FDA has issued a Warning Letter to Catalent’s Bloomington, IN, drug manufacturing plant, citing 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) that revealed significant CGMP deficiencies. The serious compliance designation could delay the approval and production timelines for drug products, including those from partner companies, including Regeneron and Scholar Rock, that are made at the plant.
The just-released 11/20 Warning Letter follows an FDA inspection conducted 6/23 to 7/14 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.
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.
“Mammalian hair is an extrinsic particle, could indicate microbial contamination, and generally is considered to render the product adulterated,” FDA wrote. After the facility was acquired by Novo Nordisk, the agency said a number of additional batches associated with mammalian hair contamination were released to customers, some of which were later rejected after distribution.
FDA held a 9/26 teleconference with the company, during which the agency informed Catalent and Novo Nordisk that the affected drug products did not meet CGMP requirements. Following those discussions, Novo Nordisk committed to contacting customers, and recalls were initiated for multiple products manufactured at the site.
Beyond contamination issues, FDA also cited Catalent for failing to properly investigate terminated media fills used to validate aseptic processing. The agency said more than five media fill batches had been aborted since 11/2023 without timely deviations or root cause investigations, contrary to company procedures.
FDA also criticized the company’s visual inspection program, saying it relied on broad defect categories rather than trending specific defect types such as hair or particulate matter. Investigators further identified contamination hazards related to occluded equipment surfaces, high-risk interventions during aseptic processing, and ineffective environmental monitoring methods.
The agency raised additional concerns about Catalent’s reliance on pre-shipment “tailgate” samples from stopper suppliers, rather than representative samples taken after receipt at the facility. FDA said enhanced sampling was implemented too late and inconsistently across suppliers, despite evidence that stoppers were a primary source of extrinsic contamination.
In response to the findings, FDA ordered Catalent to commission multiple independent assessments, including comprehensive reviews of its investigation system, CAPA program, supplier quality oversight, aseptic processing risks, and contamination hazards. The agency also requested detailed remediation plans, supporting data, and timelines for corrective actions.
While acknowledging Novo Nordisk’s investments in the facility, FDA said it remained concerned that contaminated products continued to be released after the acquisition. The agency urged Novo Nordisk to evaluate quality assurance oversight structures at other Catalent sites acquired as part of the transaction and to coordinate any operational changes with FDA’s drug shortage staff.
FDA gave Catalent 15 working days to respond to the Warning Letter and outline corrective actions. The agency said it may conduct a follow-up inspection to verify compliance.