FDA EIR - Melody Healthcare Private Ltd - August 24, 2018

An FDA surveillance inspection of Melody Healthcare Pvt. Ltd. was conducted from August 20-24, 2018, marking the first FDA inspection for the firm. The inspection focused on the company's manufacturing of non-sterile Active Pharmaceutical Ingredients (API) intended for human drug products for the U.S. market. This assessment followed the regulatory framework outlined in CPGM 7356.002F: Active Pharmaceutical Ingredient (API) Process Inspection and utilized ICH Q7 guidance. The inspection comprehensively covered critical systems including Quality, Facilities and Equipment, Materials, Production, and Laboratory Controls, with a specific emphasis on data integrity. The inspection concluded with highly favorable results; no significant current Good Manufacturing Practice (cGMP) deficiencies were identified, and consequently, no FDA Form 483, Inspectional Observations, was issued to the company. There were no instances of refusal during the inspection, and no physical samples were collected. Given these findings, the FDA issued a "No Action Indicated" (NAI) recommendation, signifying that no regulatory actions are required from Melody Healthcare Pvt. Ltd. at this time. Official FDA correspondence should be directed to Dr. Anil B. Ghogare, Director QA, QC & RA.