FDA 483 - Teyro Labs Private Limited - March 03, 2023

Teyro Labs Private Limited in Kanchivakkam, Tamil Nadu, India, was inspected from February 20 to March 3, 2023, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in aseptic processing procedures, process validation, quality control unit responsibilities, and equipment cleaning and maintenance, indicating a lack of adherence to cGMP requirements for drug manufacturing.