The USFDA, in a warning letter on June 11 to Lupin on the company’s Somerset facility in New Jersey, has cited repeated violations at the company's manufacturing facilities.
“Repeated violations at multiple sites demonstrate that your company’s corporate oversight and control over the manufacture of drugs is inadequate," USFDA said in the letter addressed to Vinita Gupta, CEO of Lupin.
“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 letter said.
Please read here for more on the warning letter.
Somerset cGMP violations
In its warning letter, the USFDA pointed out three major violations of current good manufacturing practices (cGMP) at the Somerset site. They include the firm's failure to establish and follow adequate written procedures over cleaning and maintenance of equipment. USFDA expressed concern that the deficiencies in cleaning procedures may lead to cross-contamination.
The second major issue was the firm's failure to establish adequate written procedures for production and process control, designed to assure that the drug products the company manufacture have the identity, strength, quality, and purity they purport or are represented to possess.
The third one was the failure to establish and follow adequate written responsibilities and procedures applicable to the quality control unit.
USFDA asked Lupin to test all reserve samples of drug products within the expiry date and released to the US market, which were manufactured on the tablet press that was found wanting in cleaning norms. In addition, the agency asked for a comprehensive and independent retrospective assessment of cleaning effectiveness to evaluate the scope of cross-contamination hazards.
The USFDA also sought a detailed summary of validation programme for ensuring a state of control throughout the product lifecycle, along with associated procedures.
“Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice, including, without limitation, seizure and injunction. Unresolved violations may also prevent other federal agencies from awarding contracts,” the USFDA said.
Lupin has 15 days to respond to the USFDA in writing.
