Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's manufacturing infractions.
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the company's Pithampur plant in the Indian state of Madhya Pradesh. The violations include poor quality control, inadequate handling of manufacturing errors and more.
The letter stems from an inspection that took place at the facility between June 14-26, 2024.
The FDA’s review of the site yielded a six-observation Form 483, which the company responded to in July. Still, the company's response and remediation efforts weren't enough to avoid the more serious consequence of a warning letter.
Viatris was formed in 2020 through the merger of Mylan and Pfizer’s Upjohn unit. The plant in Pithampur operates under the company name Mylan Laboratories Limited, according to the warning letter.
Last month, Viatris announced receipt of a warning letter—plus a related import alert on certain products—in a public statement. Details on the exact nature of the FDA write-up were unclear at the time.
In the warning letter’s first observation, the FDA chided Viatris for failing to safeguard the reliability and integrity of its quality control data during component release testing. The FDA said its inspectors pinpointed “anomalies” across four worksheets that had reported passing results. However, records at the plant showed the responsible analysts “were not physically present at the facility during testing.”
“Despite their absence, they documented both the testing process and results as if they had conducted the analyses,” the FDA said in its write-up.
Viatris took measures to correct the misstep, including implementing a data integrity remediation plan and firing certain staffers responsible for the violation, according to the warning letter, but the FDA still found these solutions lacking.
The FDA critiqued Viatris' quality systems in general, too, calling them “ineffective” and suggesting that the company’s broader quality unit “is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.”
The warning letter goes on to detail the site's ineffective handling of discrepancies and out-of-specification results following manufacturing runs, with FDA investigators again citing instances of workers mismanaging the situation.
Given the extent of the plant’s missteps, the FDA is encouraging the company to hire a consultant to help it meet manufacturing standards. The regulator is also calling for a serious overhaul of the site's data integrity oversight.
In last month’s announcement, Viatris stressed that it "immediately implemented a comprehensive remediation plan at the site" in the wake of the FDA's June inspection. “The necessary corrective and preventive actions are well underway, including but not limited to related personnel actions," the company said at the time.