FDA hands a warning letter to a Lupin subsidiary after failing to maintain cleanliness once again
From India to NJ, the core of the FDA’s instructions to Lupin subsidiary Novel Laboratories were the same: establish proper cleaning and process validation guidelines at your manufacturing sites. And after failing to do so for the third time in four years, the company has received a warning letter.
Drug residue on tablet presses and a failure to validate the manufacturing process after equipment changes were just two of the issues raised by the FDA after an inspection of a Novel Laboratories plant that led to the June 11 letter.
The FDA said that Novel Laboratories’ Somerset, NJ plant had violations of current good manufacturing practice regulations such as an inadequate cleaning procedure and quality control procedures. It’s the first violation at this site, but the third in four years for sites within the company’s network.
Novel Labs is a subsidiary of Lupin. Two of the company’s sites in India, one in Goa and another in Mandideep, were issued warning letters in 2017 and 2019, respectively, for similar cGMP violations. Those two facilities made products that, at the time, made up more than 40% of Lupin’s sales. The company did not respond to a request for comment by the time of publication Thursday.
“This is a big negative for the company … The warning letter will not only delay new approvals, thus impacting US revenues, but also increase remediation cost that will put pressure on margins,” brokerage firm Edelweiss Securities said in regards to the previous two letters.
“Repeated violations at multiple sites demonstrate that your company’s corporate oversight and control over the manufacture of drugs is inadequate,” the letter stated. “You should further comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the drug products manufactured, conform to FDA requirements at all your sites.”
The quality unit failed to establish and follow written procedures to ensure the drug was up to standards. The FDA said the cleaning protocol didn’t have adequate oversight, and the company failed to complete the required annual product review. While the company previously made commitments to strengthen operations and acknowledged a need for more quality unit oversight, it failed to provide a comprehensive assessment of all written procedures, the letter said.
Novel Labs is required to follow up with responses to the FDA for the following:
- A comprehensive assessment and remediation plan to ensure its quality control unit is given the authority and resources, including a determination of whether procedures used by the firm are robust and appropriate.
- A determination of whether the company’s quality control unit has the adequate education, training, and experience to perform its duties.
- Provisions for quality control unit oversight throughout operations to evaluate adherence to appropriate practices
- A complete and final review of each batch and its related information before the quality control unit disposition decision.