FDA 483 - Mayon's Pharmaceuticals Private Ltd - February 20, 2020

Mayon's Pharmaceuticals Pvt Ltd, a homeopathic drug manufacturer in Nagpur, India, was cited with eight observations during an FDA inspection from February 11-20, 2020. The inspection revealed significant deficiencies across quality control, production and process controls, equipment design and maintenance, and record-keeping. Key issues include inadequate product testing, incomplete batch records, lack of process validation, and insufficient microbial control procedures.