FDA 483 - Nosch Labs Private Ltd - September 13, 2024

An FDA inspection of Nosch Labs Private Limited, an Active Pharmaceutical Ingredient Manufacturer in Veliminedu, Chityal, Telangana, India, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate controls on testing equipment, use of unqualified reference standards, unvalidated analytical methods, irreproducible process validation, and unsound sampling plans for water. The firm also failed to properly evaluate returned products.