FDA WARNING_LETTER - B. Jain Pharmaceuticals Private Limited - August 29, 2018

The FDA issued a Warning Letter to B. Jain Pharmaceuticals Pvt. Ltd. following an inspection from August 13-29, 2018, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's products, The Relief Products Ring Relief (Ear Drops and Fast Dissolving Tablets), were also deemed misbranded.

Violations included failure to maintain clean and sanitary facilities, with observations of insects in raw material storage, mold-stained ceilings, and leaking containers. The firm also failed to properly clean and maintain equipment, specifically noting a cracked and exposed water system holding tank and patched piping, with no microbial test results provided for the water system. Furthermore, the quality control unit failed to provide adequate oversight for manufacturing processes. The firm's September 19, 2018, response was deemed inadequate due to a lack of supporting documentation and failure to address the scope of deficiencies.

The misbranded status of The Relief Products Ring Relief stems from their classification as prescription drugs due to potential for harmful effects, requiring supervision by a licensed practitioner, yet their labels failed to bear the "Rx only" symbol.

The FDA recommended the firm hire a qualified CGMP consultant to audit operations and evaluate corrective actions. The firm was placed on Import Alert 66-40 on January 9, 2019. The company must respond within 15 working days detailing corrective actions and a timeline for completion,