483
Kumar Organic Products Ltd.FDA 483 - Kumar Organic Products Ltd. - February 04, 2019
Record Details
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.
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ID · b617b9ff-1ca7-4dc1-a0c4-c14536e79d6c