FDA EIR - Veeda Clinical Research Pvt. Ltd. - March 24, 2017

The FDA conducted an analytical inspection of Veeda Clinical Research Private Limited in Ahmedabad, India, from March 20-24, 2017. The inspection, carried out under 21 CFR Part 320 and Compliance Program 7348.001 (In Vivo Bioequivalence), aimed to audit bioequivalence studies and bioanalytical functionality. Notably, no official objectionable conditions were observed, and a Form FDA 483 was not issued at the closeout.

However, several areas for improvement were discussed. These included the lack of access controls for freezers storing blank plasma samples, with the FDA suggesting physical locks. Documentation gaps were also identified, specifically missing preparation records for a Quality Control stock solution, although the firm successfully reconstructed this information. The FDA emphasized the importance of maintaining all experimental documentation contemporaneously.

Further discussions addressed non-contemporaneous event recording for abnormal sample reanalysis and a Standard Operating Procedure (SOP) that lacked clear limits for re-assay criteria. Veeda committed to implementing immediate event documentation and updating their SOPs to define these limits. Additionally, for studies involving multiple analytes, the firm had not conducted an assessment of the instrumental effect of one analyte on another during method validation, which they agreed to address in future studies. While procedures for internal standard variation were in place, observed patterns were highlighted for closer review.