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!
You did not take a reasonable measure and precaution related to personnel practices.
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.
You did not exclude pests from your food plant to protect against contamination of food.
Sanitary Facilities and Control
Your plant did not have adequate sanitary facilities and accommodations.
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.
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
Once again, I’m happy to be able to recommend this conference!
SAVE THE DATE
2018 Rocky Mountain Dietary Supplement Forum
October 23-24, 2018
Hotel Boulderado, Boulder, Colorado
“Excellent Forum – great topics and speakers – loved the FDA Panel”
“The speakers and content are exactly what our company is looking for and the reason we return each year.”
“Very informative – took away several ideas/workable strategies to implement immediately.”
[Comments from the 2017 Evaluation forms]
Recognizing the critical need of the dietary supplement industry to be educated on FDA requirements, local academic and scientific groups joined together in 2012 to create the Rocky Mountain Dietary Supplement Forum.
The goal was to provide an educational venue helping dietary supplement industry professionals learn what they need to know to stay current with FDA’s requirements. This included learning about current regulatory requirements, updates on raw ingredient and finished product testing, the importance of properly labeling dietary supplements, and other important topics.
The Forum is open to all dietary supplement participants industry-wide and averages over 100 in attendance from companies throughout the US.
Late last year FDA released inspection observations (483 citations) for FY 2017. The table above shows the top 10 dietary supplement (21 CFR Part 111 cGMP) inspection observations found during inspections in FY17. Significantly, failure to verify the identity of all dietary ingredients has now dropped to 9th place, down from 2nd place in FY 2016. Lack of established specifications for identity, purity, strength, and composition of finished dietary supplements continues to be a problem found at a large number of firms. Failing to establish written procedures for quality control operations moved up to #2. Subpart E observations (for Production and Process Control) together made up nearly 34% of the total observations by FDA inspectors, continuing the trend upward of the past few fiscal years.
Recently released 483 observation data from FDA for dietary supplement inspections show a troubling new trend in the retrograde direction. Although it seems that the industry has finally got the message with identity testing of dietary ingredients (which has dropped to #9 on the top list for FY2017) there have been far more citations for failure to set proper specifications for finished products* than in any previous year. Other highly-cited observations are lack of written procedures for quality control and for product complaints.
Really folks – if you STILL need those basic SOPs and specifications created, please contact me!
FDA Disclaimer: These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Inspectional observations reflect data pulled from FDA’s electronic inspection tools. These tools are used to generate the FDA Form 483 when necessary. Not all FDA Form 483s are generated by these tools as some 483s are manually prepared.
*21 CFR 111.70(e) For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement.
The course was developed by the Food Safety Preventive Controls Alliance (FSPCA) and is the “standardized curriculum” recognized by the Food and Drug Administration. The class provides training in the development and application of risk-based preventive controls.
A PCQI is a professional that can manage a Food Safety Plan at a food manufacturing or packaging facility in accordance with FSMA (Food Safety Modernization Act) Preventive Controls for Human Food. The class qualified me to:
Understand Good Manufacturing Practices (specifically 21 CFR Part 117) and Prerequisite Programs
Conduct hazard analysis and determine preventive controls
Develop and implement a food safety plan for their production facility
Define process, allergen, sanitation and supply-chain preventive controls
Implement verification, validation, recall and record keeping requirements.
Big thanks to Larisa Pavlick and Kathy Gombas for being such great instructors!
FDA has released new 483 citations data for FY 2017 and partial data for FY 2018. Included in their new spreadsheet are citations under 21 CFR 117, the new food cGMPs that were introduced as a result of FSMA.
To see the complete list, go to this chart, enter % in the search box, and choose the 21 CFR 117 radio button.
FDA just released fiscal year 2017 inspection classification data. The data show that inspections of dietary supplement firms appeared to have less problems in 2017 than prior years. The rate of OAI (official action indicated) classifications dropped to less than 4%, compared with around 8% in FY 2016 for the project area Food Composition, Standards, Labeling and Economics, under which most 21 CFR Part 111 cGMP inspections occur (but see Disclaimer below before you celebrate, these figures may change over time). Perhaps it is better to focus on the success rate – NAI (no action indicated, no 483 issued) inspections went up to over 60% of the total, compared with just over 50% in FY 2016.
This is good news if you need to look up the status of any FDA-regulated firm in their online database (but bad news if, like me, you compile charts based on those datasets – now I have to update monthly!)
FDA Disclaimer: “The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken. Therefore, this database does not represent a comprehensive listing of all conducted inspections and should not be used a source to compile official counts.
Inspections are classified (see Inspection Classifications) to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance. During the Agency assessment, classifications may be subject to change after a review of all relevant information. To maintain current knowledge of a firm’s compliance status, it may be important to recheck the Inspections Database for updates.”
If you have been a recipient of a Form 483 from FDA, you may be familiar with the fact that the citations for specific cGMPs are not included on the form at the end of an inspection (unlike Warning Letters). Some time ago I created a reverse lookup form so that you can type in partial text from the 483 and display matching citations for dietary supplement inspections. I just expanded this page to include reverse lookups for 21 CFR Parts 211 (drugs), 117 (FSMA, foods) and the old food cGMPs, Part 110. There are currently very few citations for 117, but I expect more to be released for FY 2017, later this Fall.