FDA 483 - BioMylz Pvt. Ltd. - February 09, 2026

Biomylz Private Limited, an OTC drug manufacturer in Bengaluru, India, was cited for severe deficiencies during an FDA inspection. Key issues include widespread data integrity violations, lack of thorough investigations, absence of critical production and process control procedures, and inadequate quality control oversight. The firm also failed to maintain complete laboratory records, proper equipment cleaning procedures, facility repair, and annual reserve sample examinations.