Companies that use contract manufacturing organizations (CMOs) are ultimately responsible for ensuring product quality and compliance to GMPs. Thus, it pays in more ways than one to be aware of recent FDA quality-related citations at CMOs and other vendors.
In this conclusion to the four-part series summarizing Steven Niedelman’s May 28 Govzilla webinar presentation on FDA inspections, Niedelman outlines the steps following the conclusion of an FDA inspection. Part I provided background on FDA inspection authority while Part II looked at the different types of inspections FDA conducts. Part III offered advice on interacting with FDA investigators once they are onsite.
On April 24, FDA issued a warning letter to contract testing laboratory International Trading Pharm Lab Inc., located in Paterson, N.J. Consumer Safety Officer Niketa Patel conducted the initial inspection October 15-29, 2019. This inspection resulted in a 483 and an Official Action Indicated classification due to data integrity issues.
Former FDA inspector Steven Niedelman discusses the basics of FDA inspections in a Govzilla webinar.