The inspection took place between January 27-31. The FDA inspectors found the site to be compliant and no Form 483 observations issued.
The inspection was triggered by data generated by MedPharm as part of a client’s ANDA for a generic topical product. The ANDA submission used MedPharm’s in vitro models to demonstrate the bioequivalence of the new generic to the originator in line with the new FDA guidelines. The inspection coincides with the recent expansion of the Durham facilities to triple its Center of Excellence footprint and accommodate up to 100 employees in the future.