Laws, Regulations, Guidance, and Concept Papers
- Just a few guidance documents and updates on non-guidance documents.
Enforcement:
- 3 warning letters.
- 1 warning letter in particular is a read for anyone interested in what FDA expects regarding identified errors in non-validated Excel spreadsheets.
- A limited number of recalls and import alerts this week.
- A slow summer with the US holiday in the middle likely contributed here.