Lupin Limited — FDA Warning Letter Findings

Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API. Your firm performed multiple risk assessments with the purpose to verify whether existing cleaning procedures and practices eliminate or reduce genotoxic impurities, including (b)(4) and (b)(4) impurities, generated through the manufacture of (b)(4) drugs, after you detected (b)(4) impurities in your API. You also performed risk assessments…

Failure to investigate all critical deviations. You failed to identify and investigate all critical deviations including limit excursions. For example, you obtained an out-of-specification (OOS) result of (b)(4) ppm against a limit of not more than (b)(4) ppm during execution of a cleaning verification protocol for (b)(4) . The final report records the OOS swab sample as being taken from a (b)(4) following the manufacture of batch (b)(4) and completing a Type B cleaning…

Failure to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of your intermediates and API. Your (b)(4) process for the manufacture of the API (b)(4) and (b)(4) results in quantifiable levels of (b)(4) Impurity (b)(4) at an irregular frequency. For example, you sampled and performed analytical testing to detect and quantify levels of (b)(4) and (b)(4) impurity levels…