USFDA, in its warning letter on June 11 to Lupin on the company’s Somerset facility in New Jersey, cited repeated violations at 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 its warning 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 USFDA pointed out three major violations of current good manufacturing practices (cGMP) at Somerset site. These include firm's failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. USFDA expressed concern that deficiencies in cleaning procedures may lead to cross contamination.
The second major issue raised by USFDA was the firm's failure to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.
The third one was 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 expiry and released to the US market, that were manufactured on the tablet press that was found to be inadequate cleaning procedure, in addition the agency asked for a comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards.
USFDA also sought a detailed summary of the validation program for ensuring a state of control throughout the product life cycle, along with associated procedures.
Test reserve samples of drug products for potential cross-contamination
"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.," USFDA said.
Lupin has 15 days to respond to USFDA in writing following the receipt of the warning letter.