PHARMACEUTICAL 483 SAMPLER by Dave Cortes
Approx. 4,000 words.
Published on March 25, 2012.
If Today an FDA auditor arrives unannounced to your Pharmaceutical Plant, there is a 54.1% chance that you will be receiving a dreaded 483 with a list of observations. You will find here:
5 FDA Observations:
1.Observation for Training.
2.Observation for Facilities and Equipment.
3.Observation for Quality systems
4.Observation for Production Systems.
5.Observation for Cleaning Validation