Inspections and Audits

FDA to Recognize GMP Inspections From Eight EU Countries

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

Apotex Facility in India Flagged for GMP Non-Compliance

An Apotex Research facility in Bangalore, India was cited for non-compliance with GMP requirements after an inspection in November by the UK’s Medicines and Healthcare products Regulatory Agency revealed non-sterile conditions, packaging issues, and inadequate testing. Read More

FDA Updates Priority ANDA Pre-submission Guidance

Responding to changes introduced by the GDUFA II program, the FDA revised its draft guidance on sponsor pre-submissions of facility information used to assess the need for manufacturing site inspections for priority applications. Read More