FDA 483 - Cipla Limited - August 26, 2022

The FDA Form 483 details significant deficiencies in aseptic processing, environmental monitoring, cleaning, and data integrity at a facility manufacturing Suspension and Solution for the US market.

**Environmental Monitoring and Aseptic Processing:** * Aseptic processing areas lack an adequate system for monitoring environmental conditions, failing to ensure microbial contaminants in critical areas are recognized and investigated. * From August 2018 to January 2019, multiple aseptically filled sterile batches (e.g., Batch, Batch Solution, Batch Suspension) were rejected due to environmental monitoring excursions from filling lines. Investigations attributed these to sampling errors, but no actions were taken to investigate the trend or implement CAPAs. * In January 2019, a change control (1003-D-19-00006) was approved to eliminate monitoring of Grade A fill and other Grade A surfaces, without discussing historical out-of-limit results. This discontinuation means no data exists to assess potential surface excursions impacting US market batches from January 2020 to July 2022. * For some products, Grade A monitoring was discontinued or assigned incorrect Grade C limits (e.g., CFU alert, CFU action vs. Grade A CFU), leading to uninvestigated microbial growth in Grade A areas (e.g., CFU on Feb 11, 2022; CFUs on Feb 26