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The FDA flagged a Shilpa Medicare facility in Telangana, India for numerous violations including noncompliant labeling, sterility procedures and testing methods. Read More
The FDA cited Impax Laboratories after an inspection revealed a significant discrepancy in the operational qualification of its packaging line’s tablet counter/elevator. Read More
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More