FDA Threatens GlaxoSmithKline, Smuthri With Refusal of API Imports
The Food and Drug Administration told two drug companies in separate warning letters it will refuse entry of their active pharmaceutical ingredients (APIs) unless they correct violations of current good manufacturing practice requirements (CGMP). In a letter dated March 18…
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sent to GlaxoSmithKline (here), FDA said CGMP violations at the company’s Cork, Ireland facility may result in APIs from that facility being placed on import alert and being refused admission. Meanwhile, an agency warning letter dated March 6 told Smruthi Organics in India that its APIs will continue to be refused admission into the U.S. because of persisting CGMP violations (here).