FDA 483 - Vipor Chemicals Private Ltd. - February 21, 2018

Vipor Chemicals Private Limited, an API manufacturer in Vadodara, India, was cited for numerous severe Good Manufacturing Practice (GMP) deficiencies during an FDA inspection. Key issues include a non-existent independent Quality Unit, widespread data integrity problems, inadequate personnel training, poorly maintained facilities and equipment, and a lack of validated processes and quality control procedures. These findings indicate a fundamental breakdown in the firm's quality system and its ability to ensure the quality, purity, and safety of its Active Pharmaceutical Ingredients.