First serialization inspections

News / Events

FDA publishes first warning letter

Have you considered these points?

Lacking packaging data (lot number, expiry date), incomplete data archiving, data integrity violations and insufficient tracking of suspect lots are the subject matter of the current warning letter. The drug supply chain security act (DSCSA) requires serialization in the USA since November 2017. Its requirements are similar, but not equivalent to the requirements in Europe.

Besides serialization non-compliance, the FDA addresses data integrity violations. In recent years, deficiencies in data integrity practices are more and more frequently criticized in warning letters.

Therefore, data integrity will be addressed in our web-seminar series again. We will introduce you to the current data integrity guidelines. You can already sign up for free to attend our web-seminars.

You have further questions or want your procedures to be audited? Contact us without obligation. We will be glad to help you.