FDA Inspection Citations: FSMA

I recently uploaded the latest FDA 483 citations spreadsheet which includes an increasing number of citations for FSMA-related inspections (as defined by 21 CFR  Part 117).  The data are current thru 2/15/2018.    At present the list of most popular observations resembles the old 110 food cGMPs, but there are 10 citations (out of a total of 856 under the new FSMA cGMPs) for problems with hazard analysis and control, indicating FDA is starting to require hazard analysis and food safety plans (if indicated by the hazard analysis, i.e. 117.130(a)(1) Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control.)

If you are subject to the FSMA regulations on Preventive Controls, this might be a good time to start working on them!

CFR # Short Description Long Description Frequency Cited
117.1 Personnel You did not take a reasonable measure and precaution related to personnel practices. 78
117.4 Equipment and Utensils – Design and Maintenance Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. 66
117.35(c) Pest Control You did not exclude pests from your food plant to protect against contamination of food. 54
117.37 Sanitary Facilities and Control Your plant did not have adequate sanitary facilities and accommodations. 47
117.80(c) Manufacturing, Processing, Packing, Holding – Controls You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food. 42
117.35(a) Sanitary Operations – Plant Maintenance You did not maintain your plant in a clean and sanitary condition and keep your plant in repair. 29
117.35(a) Sanitary Operations – Plant Sanitation You did not clean and sanitize your utensils or equipment in a manner that protects against contamination. 25
117.35(d) Sanitation of food contact surfaces – frequency You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against contamination of food. 25
117.35(e) Sanitation of non-food contact surfaces – frequency You did not clean your non-food contact surface in a manner and as frequently as necessary to protect against contamination. 24
117.20(b) Plant Construction and Design Your plant was not constructed to facilitate maintenance and sanitary operations. 20
117.35(a) Sanitary Operations – Plant Maintenance You did not keep your plant in repair. 19
117.20(a) Grounds You did not keep the grounds around your plant in a condition that would protect against the contamination of food. 16
117.35(b)(1) Cleaning and sanitizing substances- safe and adequate You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the conditions of use. 16
117.80(c) Manufacturing, Processing, Packing, Holding – Controls You did not conduct operations under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination of food. 16
117.20(b) Plant Construction and Design Your plant was not constructed and designed to facilitate maintenance and sanitary operations. 16
117.35(a) Sanitary Operations – Plant Maintenance You did not maintain your plant in a clean and sanitary condition. 15
117.93 Storage and Transportation You did not store or transport food, including ingredients, under conditions that protect against contamination. 12
117.130(a)(1) Hazard Analysis – Identification of Hazard Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control. 10
117.20(b) Plant Construction and Design Your plant was not designed to facilitate maintenance and sanitary operations. 10

Note: My Top 25 dietary supplement citations chart now reflects 483 data up to mid-February 2018, and will continue to reflect the latest data as it is posted by FDA.

USP Tools for GMP Compliance – Dietary Supplements

Very useful USP cGMP class to be held in UTAH!

USP Tools for GMP Compliance – Dietary Supplements

This training course will help you implement practical solutions within your organization for complying with dietary supplement GMP requirements that are often the focus of regulatory inspections. You will learn practical scientific approaches for complying with 5 key GMP requirements listed below:

• Establishing ingredient and finished product specifications
• Qualifying analytical instrumentation
• Validating analytical test procedures
• Understanding skip-lot testing and determining when and how to conduct it
• Qualifying suppliers of components

USP standards —which are established by independent scientific experts – form the basis for the information to be provided. Additional insight is provided based on the instructor’s extensive industry experience working with many dietary supplement manufacturers in the USP Dietary Supplement Verification Program.
This training course is designed for individuals in quality assurance, quality control, production and management who already have a basic general understanding of GMP requirements. It is designed to give students an in-depth understanding of best practices related to specific GMP concepts. The course will provide actual workplace case studies and direct one-on-one interaction to facilitate your learning and test your understanding of the material.
Please note the new date is May 11, 2018.

Register Now

Event Details
Date: May 11, 2018 (NEW DATE)
Time: 9:00 AM-5:00 PM
Location: Utah Valley University
Address: Sorensen Student Center
Room: Conference Rooms SC 213A and 213B
800 West University Parkway,
Orem, Utah, 84058