USFDA revokes warning to Cadila Healthcare
17 Jul 2012
The US Food & Drug Administration (USFDA) has revoked its earlier warning letter to Ahmedabad-based Cadila Healthcare Ltd and has now written to the company informing that its facility at Moraiya meets the necessary norms.
The FDA had, in June, issued a warning letter to Cadila stating that the company had failed to meet the US FDA's drug manufacturing standards.
The FDA had reported significant violation of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at Cadila's Moriya plant.
"These violation cause your drug products to be adulterated" the FDA had stated in its letter.
The warning was based on inspections carried out at the facility, which is used to make tablets, capsules and injectible drugs.
"During our January 17 – February 3, 2011 inspection of your pharmaceutical manufacturing facility, at Moraiya, Gujarat, investigators from FDA identified significant violations of Current Good Manufacturing Practice regulations for finished pharmaceuticals," US FDA had said in its letter then.
