Usv Limited – FDA Warning Letter, Jun 11, 2013

An FDA inspection of USV Limited's control laboratory in Mumbai, India, from June 7-11, 2013, revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm's responses dated July 1, August 29, and December 5, 2013, were deemed insufficient. Key violations included the failure to follow and document required laboratory control mechanisms, specifically backdating balance weight printouts for sample weights used in calculations for method validations submitted in FDA drug applications. This data manipulation raised serious concerns about the reliability and accuracy of all data generated by the firm. Additionally, the firm failed to exercise appropriate controls over computer systems, lacking adequate procedures for their use in the QC laboratory. Investigators found that users could delete data, audit trail functions were disabled on GC and XRD systems, and multiple QC personnel shared login IDs for HPLCs, XRD, and GC workstations. These deficiencies led the FDA to question the effectiveness of the firm's quality system. USV Limited is required to hire a third-party auditor to address data integrity issues, provide a comprehensive computer life cycle program, and submit a list of all U.S.-shipped drug products relying on inaccurate data. Failure to correct these violations may result in the FDA withholding approval of new applications and refusing admission of articles into the United States.