Guidance documents are available from the FDA and EMA this week across a variety of topics. Lots to read there from both the FDA and EMA.

Enforcement publications were busy this week:

  • 3 drug warning letters from FDA (2 were to OTC manufacturers)
  • 2 reports of EU GMP non-compliance
  • 2 forms 483 from sites in India

A collection of Class II and III recalls and a few import alerts (including one for refusal of an inspection).

For those who follow data integrity issues or audit in this area, we previously announced that Rx-360 published an Audit Manual for the topic. It’s free to download. There will be a webinar to address the content on May 14th 2018. This is also free, register HERE.