US FDA issues warning letter to USV Limited for data integrity

The US FDA issued a warning letter to USV limited for failing to ensure the data integrity at a control laboratory. USV limited is a manufacturer of API’s, peptides, solid oral dosage forms and biologics. This letter has been issued in view of two specific cGMP violations relating to data produced at the facility.

FDA inspected the site in Mumbai, India and claimed that the firm failed to follow and document required laboratory control mechanisms as well as failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records. The letter states, The lack of reliability and accuracy of data generated by your firm is a serious cGMP deficiency that raises concern for all data generated by your firm.

FDA also criticized an array of practices at a testing laboratory, including the use of sample measurements - as opposed to measurements actually recorded during an analysis - to calculate impurities. The regulators also warned USV for purportedly failing to enact safeguards that would prevent unauthorized staffers from altering records about drug quality.