USFDA issues warning letter on Lupin's Somerset facility, cites repeated violations at company's manufacturing facilities

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.

Lupin has 15 days to respond to USFDA in writing following the receipt of the warning letter.