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.
The facility’s management blamed the water damage on a monsoon that occurred before the inspection, but there were signs of longer-term water and humidity issues, such as rusting pipes and warped walls.
An operator was seen entering unreliable data for the visual inspection test of a batch and portions of the documentation were completed without required data. The agency called for a retrospective assessment of other instances of inaccurate data reporting.
In addition, the firm failed to expand OOS investigations in a timely manner to address possible manufacturing problems. For example, OOS results that revealed an impurity after a stability test of injection batches were blamed on “poor column efficiency.” No specific root cause was found, but the analyses were repeated and the OOS results were invalidated after achieving passing results.