Recent FDA data confirms that the focus of dietary supplement cGMP inspections has continued to evolve in favor of enforcing the regulations on product specifications and the required standard operating procedures (SOPs) for quality control operations and product complaints.

The data show the continued importance of developing complete product specifications for identity, purity, strength, and composition; creating written procedures for quality control operations and for handling product complaints. Batch records continue to be a source of non-compliance.  However, identity testing of dietary ingredients, along with developing proper specifications for raw materials, is still a high priority.

The trends are shown in the chart below: the red line represents the citations for failure to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.  This was the top citation in the earlier years of cGMP enforcement of 21 CFR Part 111, the dietary supplement cGMPs, a trend that started to reverse in 2015 in favor of product specifications and documentation issues.

The data above is derived from the chart at:

https://www.marianboardley.com/charts/stacked_bar_chart.php

* Data are incomplete for Fiscal Year 2019 – current thru 9/11/19

** Represents observations recorded on electronically-generated Form 483 during inspections. Not all inspections are included in the database. For example, inspections waiting for a final enforcement action are not included.