FDA 483 - Vimta Labs Limited - March 17, 2023

An FDA inspection of Vimta Labs Limited's control testing laboratory in Hyderabad, India, revealed significant deficiencies in equipment cleaning, maintenance, and environmental controls. Observations included visible corrosion and residue in sterility testing areas, growth in incubators, and a broken differential pressure gauge. Additionally, the firm lacked sufficiently detailed written procedures for equipment cleaning and maintenance.