The USFDA warned that three serious violations of current good manufacturing practice (cGMPs) were found at the Somerset site in its warning letter.Live bsense Live Volume Todays L/H PlusUSFDA issued a warning letter to Lupin on June 11 regarding the Somerset facility in New Jersey. It cited numerous violations at the company's manufacturing plants."Repeated violations at multiple locations demonstrate that your company's corporate oversight is insufficient," USFDA warned Vinita Gupta (CEO of Lupin) in a warning letter.The letter stated that you should conduct a comprehensive assessment of your company's global manufacturing operations in order to make sure that all systems and processes and, ultimately, drug products manufactured at your locations, comply with FDA regulations.For more information on the warning letter, please click hereSomerset cGMP violationsThe USFDA warned that there were three serious violations of current good manufacturing practice (cGMPs) at the Somerset site. They include the failure to follow proper written procedures for cleaning and maintaining equipment. The USFDA expressed concern about cross contamination due to insufficient cleaning procedures.The USFDA also raised concerns about the failure to create adequate production and process control procedures to ensure that your drug products are of the same quality, strength, and purity as they claim to be.Third, failure to follow appropriate written responsibilities and procedures for the quality control unit.USFDA requested Lupin to test all reserved drug products that had expired and were released to the US market. Lupin was also asked to perform a retrospective comprehensive assessment of your cleaning performance to determine the extent of cross-contamination risks.The USFDA requested a detailed summary and associated procedures of the validation program to ensure a state-of-control throughout the product's lifecycle.For cross-contamination concerns, test reserve samples of drug products"Failing to address the matter promptly and properly may lead to regulatory or legal action, including seizure or injunction. The USFDA stated that unresolved violations could also prevent Federal agencies from awarding contracts.After receipt of the warning letters, Lupin has fifteen days to reply to the USFDA in writing.
