GMP: EU GMP Non-Compliance Report might lead to FDA Import Stop in future
The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn't conclude though that the inspection pressure would decrease now because of the recognition of EU inspections. There is a series of exceptions to look out for. The FDA will first ask the competent authority of the EU when the last GMP inspection was performed at a site in question and which GMP deficiencies were found.