FDA 483 - JT Cosmetics & Chemicals Pvt Ltd. - February 28, 2018

QT Cosmetics & Chemicals Pvt Ltd. in Panchmahal, Gujarat, India, an OTC drug manufacturer, was cited for severe deficiencies across its quality, production, laboratory, facility, and material systems. The inspection revealed a lack of fundamental GMP procedures, including an independent Quality Unit, proper investigations, employee training, process validation, and environmental controls. Significant issues included falsification of Certificates of Analysis, inadequate batch records, and evidence of pest infestation and equipment deterioration.