FY 2016 Drug Inspection Summary

From October 1, 2015 to September 30, 2016, 691 Form 483’s were issued to Drug Manufacturers, which resulted in 3,342 individual citations. The frequency of citations ordered by subpart of 21 CFR 211 provides the following insight as to inspection trends identified by FDA for Fiscal Year 2016.

As you can see in the above table, Subpart I accounts for ~ 20% of all the identified citations. Within the Laboratory Controls Subpart, 4 citation references accounted for 57.5% of the total findings. The top 4 findings within the Laboratory Controls area are:

Does your Laboratory Controls program have similar deficiencies?

Brad Henry

Vice President of Services Products - Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.

Schedule with Brad Henry

John Underwood

Vice President of Services Delivery - With over 20 years of industry experience, John has been fortunate enough to experience all levels at PV and has provided services to the pharmaceutical and medical device manufacturing industries. He has extensive experience in dry products, parenteral, facilities and utilities, API, and computer systems.

Schedule with John Underwood

Brad Henry

Schedule with Brad Henry

John Underwood

Schedule with John Underwood