Baxter Facility Warned for Serious Production Failures

Baxter subsidiary Claris Injectables was hit with a warning letter for significant water damage, falsely recording data and neglecting to properly investigate out-of-specification results at its Ahmedabad, Gujarat facility.

The FDA investigators observed the serious deficiencies during an inspection of the facility from July 27 through August 4, 2017, including water stains, puddles and warped ceiling panels.

They found water damage in vents, sky lights and ceilings over the firm’s finished drug product packaging area, as well as the personnel corridor outside the facility’s quality control laboratory. The personnel corridor also had unsealed ceiling panels that allowed air into post-sterilization areas.