Bioequivalence and Bioavailability Forum

Examples of FDA's 483 form [Bioanalytics]

posted by Jaime_R – Barcelona, 2007-10-31 12:16 (6813 d 00:11 ago) – Posting: # 1263
Views: 5,683

Dear Ramesh!

❝ It would be more helpful if i get the notice(483) issued by the FDA.

I'm sure you don't really want to get a FORM FDA 483 (INSPECTIONAL OBSERVATIONS) issued.
Some examples of 483s can be found here.

As Ohlbe already said, he couldn't find a warning letter; but if you want to give it a try yourself, here is the site to search.

Complete thread:

• warning letter given for QC's not covering the sample conc Ramesh 2007-10-26 04:57 
  • warning letter given for QC's not covering the sample conc Ohlbe 2007-10-31 00:36
    • warning letter given for QC's not covering the sample conc Ramesh 2007-10-31 04:06
      • Examples of FDA's 483 formJaime_R 2007-10-31 11:16