The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March.
The letter for Talegaon Dabhade, India-based Badrivishal follows a three-day inspection from last August in which FDA uncovered that the site’s water purification system was not adequately monitored and controlled.
The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March.
The letter for Talegaon Dabhade, India-based Badrivishal follows a three-day inspection from last August in which FDA uncovered that the site’s water purification system was not adequately monitored and controlled.
– See more at: http://www.raps.org/Regulatory-Focus/News/2017/03/14/27110/New-FDA-Warning-Letters-Highlight-CGMP-Deviations-at-API-Plants-in-China-India/#sthash.ImXZlBmB.dpuf
http://www.raps.org/Regulatory-Focus/News/2017/03/14/27110/New-FDA-Warning-Letters-Highlight-CGMP-Deviations-at-API-Plants-in-China-India/