FDA 483 - LUPIN MANUFACTURING SOLUTIONS LIMITED - July 06, 2016

This FDA Form 483 documents observations from an inspection of a facility involved in finished Active Pharmaceutical Ingredient (API) production, specifically for products like REDACTED and REDACTED USP. The primary observation concerns the firm's failure to validate disinfectant and sanitization procedures used in clean controlled manufacturing areas, potentially compromising product quality.

The firm fumigated its Plant REDACTED, specifically the clean controlled Powder Processing Areas, multiple times (REDACTED in 2014, 2015, and 2016) using a REDACTED disinfectant solution. This fumigation, conducted according to SOP AMP-044-02, "Fumigation in Powder Processing Area," effective 6/25/2016, occurred after microbiological environmental monitoring alert levels were exceeded. The procedure involves aerosolizing the REDACTED solution to cover the entire room. While equipment and most products are removed, product in REDACTED drums, if unable to be removed, are to be covered to prevent cross-contamination.

The firm failed to validate that the method used to cover product drums prevents contamination from fumigation agents and did not establish that product quality is not impacted by the fumigation. Additionally, the fumigation logs did not record which product drums were left in the rooms during the process. This indicates deficiencies in quality system controls related to environmental control and product protection.