Draper, Utah: May 29 2014
I will be presenting an “Overview of Recent FDA Enforcement Activities in Dietary Supplements” at this FREE PerkinElmer event on “Analytical Testing of Dietary Supplements“. The meeting is focused on quality control for supplement manufacturers and includes sessions on metals testing and FTIR for botanical ingredients. The seminar will be held on May 29 in Draper, Utah. See flyer for more details and registration.
Abstract for my session (scheduled after lunch):
“Good Manufacturing Practices for Dietary Supplements (21 CFR Part 111) have now been in place for over 5 years. FDA recently stated that around 70% of dietary supplement firms inspected so far have been found to have one or more CGMP defects or violations. FDA periodically releases information on its enforcement activities, such as inspection observations provided to firms via 483’s, and Warning Letters. This presentation gives an overview on what these data reveal about industry compliance, with a focus on laboratory operations, testing, and analytical methods”.
Hope to see you there!
New charts from FDA 483 observations are now available here.
These charts include data from FDA FY 2013 inspections. They use MySQL/PHP and Google Charts.
The old-style charts are archived
One and a Half day In-Person Seminar
The cost of non-compliance with regulatory standards within the dietary supplement industry has already been big. Several firms have suffered irreparable damage to their reputations for failing to implement and maintain strong laboratory compliance and testing programs. Make sure that your organization’s laboratory compliance program is effective and tailor-made in light of the key risk factors within your organization.
This seminar will provide an overview of the importance of the role of the laboratory within your larger quality organization in implementing and maintaining a strong testing compliance program. We’ll review enforcement action case studies and discuss how they might have been prevented. We’ll also review key internal controls that can help prevent laboratory non-compliance becoming a problem during an FDA inspection.
Location: Houston, TX
Date: Thursday, March 20, 2014 and Friday, March 21, 2014
If you are looking for information about the 2015 Rocky Mountain Dietary Supplement forum please click here
Rocky Mountain Dietary Supplement Forum
How to Effectively Work with FDA
A two-day seminar to learn directly from industry experts
September 12-13, 2013 Boulder, Colorado
- Learn how to dramatically change the outcome of your inspection with the Agency
- Hear from FDA Denver District representatives about what they expect during an inspection
- Interact with other industry professionals who are facing the same challenges you are
Contact Marian for more details.
I will be speaking in Iselin, NJ and Portland, Oregon
during the upcoming PerkinElmer tour.
Evidence from recent FDA Warning Letters and 483’s issued to dietary supplement firms under current good manufacturing practice regulations (21 CFR 111 cGMP’s) indicates that FDA is stepping up its focus on laboratories and testing. This presentation outlines the common laboratory compliance problems FDA is finding during inspections, and shows how those issues can easily escalate into Warning Letters if not properly corrected.
Details are here: http://web2.perkinelmer.com/INTour-2013
Hope to see you there!
I’m pleased to announce that FDA has posted the Turbo EIR data for inspection observations (483’s) for FY 2011 & FY 2012.
I will be working on some new charts in the next couple weeks, but here is some preliminary data. As you can see, ‘Component – verify identity, dietary ingredient’ — aka 21 CFR 111.75(a)(1)(i) — became an even bigger issue during 2012 inspections than in previous years, and now leads as the most cited item for all years combined (for inspections under 21 CFR 111 GMP’s.) Having proper SOP’s in place for product complaints and QC operations remains a big priority, along with complete specifications/MMR/BPR and supplier qualification.
There were a total of 1964 21 CFR 111 observations entered into the FDA TurboEIR system in 2012, compared with 1328 (2011); 631 (2010); 130 (2009).
Top 483 observations FY 2008 – 2012 total:
|Component – verify identity, dietary ingredient
|Specifications – identity, purity, strength, composition
|Written procedures – product complaint
|Written procedures – quality control operations
|Component – qualify supplier
|Batch record – complete
|Specifications met – verify; finished batch
|Master manufacturing record – unique formulation
|Master manufacturing record – each batch
|Written procedures – holding
|Specifications-component purity, strength, composition
See http://www.fda.gov/iceci/EnforcementActions/ucm250720.htm for more information about this data and how it is gathered.