FDA 483 - Hy-Gro Chemicals Pharmtek Pvt. Ltd. - May 22, 2025

Hy-Gro Chemicals Pharmtek Pvt. Ltd. in Bollaram Village, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate drug product release testing, specifically regarding risk assessment for carcinogen formation and stability studies, as well as a lack of microbial speciation for non-sterile APIs. The firm also failed to properly inspect electronic equipment for power disruptions and maintain an adequate preventative maintenance program, leading to unassessed analytical equipment failures and potential data integrity issues.