FDA 483 - Teena Bio Labs Private Ltd - February 09, 2018

Teena Biolabs Pvt Ltd, a control testing laboratory in Hyderabad, India, was cited for significant deficiencies in laboratory controls, including scientifically unsound test procedures and failure to follow established specifications. The inspection revealed issues with microbiological enumeration testing, particle size distribution methods, and instrument calibration, indicating a lack of assurance in drug product quality and purity. These findings suggest a moderate level of severity regarding quality system compliance.