FDA 483 - Valens Molecules Private Limited

An FDA inspection of Posh Chemicals Private, Ltd. in Hyderabad, India, an API manufacturer, from March 30 to April 06, 2015, revealed significant deficiencies across multiple areas. The firm exhibited inadequate employee training, a lack of validation for test methods and laboratory equipment, and poor laboratory controls. These observations indicate a systemic failure to adhere to current Good Manufacturing Practices, posing a risk to the quality and purity of drug substances.