Kumar Organic Products Ltd. – FDA 483, Feb 4, 2019

Kumar Organic Products Ltd. in Bangalore, India, received a Form 483 with four observations during an inspection of their Active Pharmaceutical Ingredient (API) manufacturing facility. The inspection revealed significant issues including inadequate investigations into out-of-specification batches, deficiencies in cleaning validation, insufficient cleaning procedures for critical rooms, and a failure to follow written procedures for annual product quality reviews. These findings indicate a lack of robust quality control and adherence to established protocols.