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.
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.
Classifications for FDA inspections during the first half of FY 2016 (Oct 2015 thru March 2016) were released by FDA a few weeks back. The above chart shows inspection outcomes under CFSAN (which includes foods and dietary supplements). The number of 483s issued in the area of “Food Composition, Standards, Labeling and Economics” continues to decline slightly — just short of 60% of inspections in that area now result in no 483 being issued. Most DS inspections occur in that project area, along with “Foodborne Biological Hazards” (which also applies to regular food facilities.) See more by clicking on the chart.
I will be speaking along with 3 other presenters at this workshop on
Wednesday, October 05, 1:30 PM – 4:30 PM
Laboratory testing of ingredients and finished goods is top-of-mind in the natural products industry. Beyond the media coverage of testing methods lie a host of concerns from qualifying and selecting an appropriate laboratory partner to method validation, audits and supply chain integrity. Explore the current state of affairs and join the discussion around how appropriate testing and information sharing throughout the product development process is critical to efficacy and safety.
What should a laboratory audit entail and can a lab meet specific testing needs
The GMP testing requirements and their impact on manufacturers and marketers
Supply chain management and the role of testing throughout the chain
The Dark Issue is the most talked about issue in NBJ history and we’re ready to talk about it some more. Join us March 30 at 2 p.m. eastern standard time for a webinar examining some of the biggest challenges facing the supplement industry. Topics to be discussed include:
Adulteration in the supply chain
Best use of scientific studies
Spiking in sports medicine
GMP violations and FDA Warning Letters
Retailers as gatekeepers
What the industry is doing to hold onto consumer trust
What a new approach to regulation could mean
The first quarterly webinar of 2016 will feature presentations and discussion with:
Council for Responsible
The presentations will be followed by what we expect to be a lively Q&A. The Dark Issue webinar is free to subscribers, or with a purchase of the Black Issue Extended Edition. Or buy a seat for $95.
FDA released new spreadsheets for FY 2015 (10/1/2014 – 9/30/2015) which have now been incorporated into my charts.
The total number of observations found during cGMP inspections at dietary supplement firms has declined from FY 2014 (the peak was in FY 2013). Production and Process Control (Subpart E) citations continue to dominate, consisting of ~30% of the problems found. In FY 2015, finished product specifications for identity, purity, strength, composition (and for limits on contaminants) remained the most frequent item (as it was in FY 2014) but by a greater margin. Identity testing of components, followed by batch record requirements, continue to top the list of inspectors’ favorite inspection findings.
There are myriad considerations around selecting and working with a contract manufacturer/private label provider and understanding them could be the difference between a successful product launch with a long-term partner, and a disappointment in the market. Experts in the field share their insights into auditing and qualifying suppliers for GMP compliance, understanding finished product specifications and your obligations, risk assessment, and best practice tips for selecting the right manufacturing partner.