• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Blogs
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Blogs
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    Healthy Snacking: Matching Lifestyle with Nutrition

    Vitamins & Minerals: Traditions in Preventive Health

    Fiber Revisited: Closing the Gap

    Green Power for Future Generations

    2019 International Buyers' Guide
    Blogs & Guest Articles
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Live From Shows
    Top News
    PepsiCo to Acquire CytoSport from Hormel Foods

    Study Shows Collagen Peptides Aid Runners in Injury Recovery

    Glanbia Nutritionals to Acquire Watson

    Alkemist Labs Cuts Testing Turnaround Time by 20%

    Jim Emme to Receive American Botanical Council Champion Award for 2018
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    PepsiCo to Acquire CytoSport from Hormel Foods

    Study Shows Collagen Peptides Aid Runners in Injury Recovery

    Podcast: Talking Hemp & CBD 101 with AHPA’s Jane Wilson

    Jim Emme to Receive American Botanical Council Champion Award for 2018

    GOED Releases Updated Omega-3 Ingredient Market Report
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    PepsiCo to Acquire CytoSport from Hormel Foods

    Study Shows Collagen Peptides Aid Runners in Injury Recovery

    Glanbia Nutritionals to Acquire Watson

    Alkemist Labs Cuts Testing Turnaround Time by 20%

    Podcast: Talking Hemp & CBD 101 with AHPA’s Jane Wilson
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    Study Shows Collagen Peptides Aid Runners in Injury Recovery

    Podcast: Talking Hemp & CBD 101 with AHPA’s Jane Wilson

    Afrigetics Botanicals Sponsors Bulbine through ABC’s Adopt-an-Herb Program

    Research on Stratum Eggshell Membrane Explores Benefits for Cartilage Protection

    New Monograph on Centella asiatica Looks to Expand Use and Applications
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Sabinsa Corporation

    PLT Health Solutions

    Herbally Yours

    Watson Inc.

    BatchMaster Software, Inc.
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Watson Inc.

    PLT Health Solutions

    Shanghai Freemen

    BatchMaster Software, Inc.

    Sabinsa Corporation
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Columns

    Data from GMP Inspections Suggests Increased Compliance

    Recent FDA inspections of dietary supplement facilities can help the industry efficiently allocate compliance resources.

    Related CONTENT
    • American Herbal Products Association President Discusses Future of Ginseng Conservation
    • FDA Guidance Explains Certain Exemptions from FSMA
    • FDA Concludes Major Sampling Study of Sprouts
    • Partnership to Assess Accuracy of DNA Testing in Herbal Products
    • Testing Strategies in the Modern Nutraceuticals Industry
    By Merle Zimmermann, PhD, American Herbal Products Association (AHPA)01.05.18
    Data from Food and Drug Administration (FDA) inspections of dietary supplement facilities conducted in 2016 and 2017 show that FDA continues to inspect an increasing number of facilities annually, and the industry continues to get better at communicating compliance with current good manufacturing practice (cGMP) requirements to FDA inspectors.

    The American Herbal Products Association (AHPA) maintains an extensive repository of inspection data that includes FDA 483 inspection reports, inspector observation forms, establishment inspection reports (EIRs), and warning letters.

    FDA has inspected a total of 2,137 unique dietary supplement facilities (including 184 foreign facilities) between January 2010 and September 2017. The latest data show that FDA inspected 610 dietary supplement facilities in fiscal year (FY) 2017, up from roughly 475 in both FY 2016 and FY 2015. Among the 1,953 domestic inspections, 52% (1,015) of the most recent FDA inspections resulted in no recorded observations or FDA Form 483s.

    Since 2011, FDA has increased inspections of all facilities. Implementation of the Food Safety Modernization Act (FSMA) is reflected in an increasing number of dietary supplement facility inspections and re-inspections. Of the 35% of facilities visited more than once, more than half of those (18% of all inspected facilities) were revisited by inspectors within two years of the previous inspection. Under FSMA, FDA’s goal is to inspect “at least” every five years, or every three years for facilities the agency deems are “high risk.”

    While the data suggest that FDA inspectors are finding more facilities in compliance with cGMP requirements (21 CFR 111), some sections still frequently appear in FDA Form 483s. The most frequent sections of 21 CFR 111 to appear in FDA 483s were:

    Specifications
    • 111.75: How a facility determines whether specifications are met
    • 111.70: Specifications that must be established

    Master Manufacturing & Batch Production Records
    • 111.205: The requirement to establish a master manufacturing record
    • 111.210: What the master manufacturing record must include
    • 111.255: The requirement to establish a batch production record
    • 111.260: What the batch record must include

    Written Procedures for Quality Control
    • 111.103: Requirements for written procedures

    Sanitation Requirements
    • 111.15: Sanitation requirements applying to the physical plant and grounds
    Developing Effective Intervention Strategies
    Immediate investigation and intervention occasionally reduces an observation into a discussion item. In these cases, actions taken during inspection were discussed prior to, or at closeout with inspector. These discussions were recognized and recorded by FDA staff in their establishment inspection reports. Keeping this in mind helps facilities develop a “ladder” of intervention strategies.

    1. Making Immediate Changes
    Conditions that can be fully addressed during an inspection and shown to the inspector prior to closeout can result in a discussion item on an EIR rather than an observation on an FDA Form 483.

    2. Providing a Clear Path to a Solution
    If it is impossible to correct a condition observed by an FDA inspector immediately and directly, preparing and scheduling the implementation of new procedures (including appropriate staff training) to remedy the circumstances may effectively address a potential observation, and should help if it does end up appearing as an observation.

    3. Making a Commitment During an Inspection
    Showing that the solution is coming helps. Providing a schedule and plan for addressing a problem demonstrates an active engagement and a clear road and commitment to improvement. Following through, regardless of whether a potential problem appears as a discussion item on an EIR or an observation on an FDA Form 483, is essential.
    Implement commitments prior to the next re-inspection, and follow any timelines as proposed as much as possible. FDA sometimes revisits facilities within a few months to check on progress. Seven percent of facilities are revisited within one year of their previous inspection, and more than half of those inspected more than once are seen by FDA again within two years.

    Resource Allocation
    The data from recent FDA inspections of dietary supplement facilities can help the industry efficiently allocate compliance resources to effectively communicate how facilities are complying with cGMP requirements when FDA inspectors visit.

    If you are interested in more detailed analysis of cGMP inspection data, check out AHPA’s recent webinar: http://bit.ly/2BYP7Gb. 


    Merle Zimmermann, PhD
    American Herbal Products Association (AHPA)

    Merle Zimmermann, PhD, is chief information analyst, at the American Herbal Products Association (AHPA). He maintains and updates several online resources that serve the herbal products industry, including an online searchable database of new dietary ingredients submitted to the FDA and the online version of AHPA’s Botanical Safety Handbook. Dr. Zimmermann is currently working to expand the Botanical Identity References Compendium, a centralized source of information containing examples and techniques that have been successfully applied to authenticate and qualify selected botanical materials. Dr. Zimmermann earned his PhD in Chemistry from the University of Maryland.
    Related Searches
    • Quality Control
    • Dietary Supplement
    • Botanical
    • fsma
    Suggested For You
    American Herbal Products Association (AHPA) American Herbal Products Association (AHPA)
    State of the Industry: What Lies Ahead? State of the Industry: What Lies Ahead?
    FDA Warns Against SARMs in Body-Building Products FDA Warns Against SARMs in Body-Building Products
    FDA Considers Revoking Soy Protein’s Authorized Heart Health Claim FDA Considers Revoking Soy Protein’s Authorized Heart Health Claim
    Medical Foods Regulation: FDA’s Restrictive View Stifles Innovation Medical Foods Regulation: FDA’s Restrictive View Stifles Innovation
    AHPA Supports Appalachian Beginning Forest Farmer Coalition (ABFFC) AHPA Supports Appalachian Beginning Forest Farmer Coalition (ABFFC)
    AHPA Publishes Guidance on Foreign Matter Limits in Herbal Ingredients AHPA Publishes Guidance on Foreign Matter Limits in Herbal Ingredients
    UNPA Offers Education and Training for Food and Supplement Companies UNPA Offers Education and Training for Food and Supplement Companies
    Dietary Supplement Caucus Briefing Covers Nutritional Intakes of U.S. Adults Dietary Supplement Caucus Briefing Covers Nutritional Intakes of U.S. Adults
    Partnership to Assess Accuracy of DNA Testing in Herbal Products Partnership to Assess Accuracy of DNA Testing in Herbal Products
    Testing Strategies in the  Modern Nutraceuticals Industry Testing Strategies in the Modern Nutraceuticals Industry
    Building on Quality Foundations Building on Quality Foundations
    FDA Concludes Major Sampling Study of Sprouts FDA Concludes Major Sampling Study of Sprouts
    FDA Guidance Explains Certain Exemptions from FSMA FDA Guidance Explains Certain Exemptions from FSMA
    American Herbal Products Association President Discusses Future of Ginseng Conservation American Herbal Products Association President Discusses Future of Ginseng Conservation

    Related Columns

    • Dietary Supplements | Healthcare Trends | Medical Nutrition | Regulations | Research
      Nuances of the Healthcare Institutional Nutrition Market

      Nuances of the Healthcare Institutional Nutrition Market

      The opportunity for distribution of nutritional products in hospitals, rehabilitation facilities, nursing homes, and home care is growing dramatically.
      By Gregory Stephens, RD, Trish Cadwallader & Sheila Campbell, PhD, RD 01.03.19

    • Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations
      The Magical Mystery Tour Also Known as Cannabis Sativa

      The Magical Mystery Tour Also Known as Cannabis Sativa

      What’s in the new Farm Bill and what does it mean for hemp and CBD?
      By Todd Harrison & Meryl Nolan, Venable 01.03.19

    • Dietary Supplements | Healthcare Trends | Regulations | World Markets
      Personalized Nutrition: New Opportunities for Product Development

      Personalized Nutrition: New Opportunities for Product Development

      The introduction of effectively targeted solutions has strong potential to improve consumer health and well-being.
      By Joerg Gruenwald, analyze & realize GmbH 01.03.19


    • Cancer Risk | Herbs & Botanicals | Mood Health & Sleep | Quality & Safety | Research | Testing
      Botanical Science: Ginseng for Stress Response & Data Transparency

      Botanical Science: Ginseng for Stress Response & Data Transparency

      AHPA compiles recent research on botanicals and plant compounds published in peer-reviewed journals.
      By Holly E. Johnson, PhD, American Herbal Products Association 01.03.19

    • Dietary Supplements | Healthcare Trends | Medical Nutrition | Quality & Safety
      How Do Practitioners Define Dietary Supplement Quality?

      How Do Practitioners Define Dietary Supplement Quality?

      Beyond what’s in a product, quality encompasses everything from science behind a formulation to diligence of staff.
      By Erik Goldman, Holistic Primary Care 12.06.18

    • Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations
      Availability of CBD Liability Insurance (and Actual Coverage) is Often Scarce

      Availability of CBD Liability Insurance (and Actual Coverage) is Often Scarce

      The wild west of CBD is fraught with perils, not the least of which is buying liability insurance you can rely on.
      By Greg Doherty, Bolton & Company 12.06.18


    • ‘No Pain, No Gain?’ What’s the Real Story?

      ‘No Pain, No Gain?’ What’s the Real Story?

      Supplements that can tap into the potential of heat shock proteins could potentially transform the sports nutrition industry.
      By Greg Stephens & Sheila Campbell, PhD, RD, Windrose Partners 11.01.18

    • Demystifying the Regulatory Status of CBD

      Demystifying the Regulatory Status of CBD

      The hype and the legal issues surrounding cannabinoids need context, and you probably need a lawyer.
      By Todd Harrison, Venable 11.01.18

    • Assessing the Nutrition and Health Claims Regulation 10 Years Later

      Assessing the Nutrition and Health Claims Regulation 10 Years Later

      With clearer understanding, applying for a health claim is more worthwhile today.
      By Joerg Gruenwald, analyze & realize ag 11.01.18


    • Digestive Health | Mood Health & Sleep | Research
      Potential Role of Microbe-Gut-Brain Axis on Mood

      Potential Role of Microbe-Gut-Brain Axis on Mood

      Research is at an early stage in understanding the role of gut microbes.
      By Dilip Ghosh, PhD, FACN, nutriConnect 10.01.18

    • Dietary Supplements | Healthcare Trends | Regulations
      Is Google’s AdSense System Biased Against Dietary Supplements?

      Is Google’s AdSense System Biased Against Dietary Supplements?

      The company lumps drugs and supplements into a single ad category, creating an unwitting bias in favor of pharma.
      By Erik Goldman, Holistic Primary Care 10.01.18

    • Consumer Trends | Flavors & Colors | Functional Foods & Beverages
      Flavor: The New Frontier

      Flavor: The New Frontier

      A critical component of new product development, flavor should be integrated into the overall concept and marketing strategy.
      By Greg Stephens & Sheila Campbell, PhD, RD, Windrose Partners 09.10.18

    • Dietary Supplements | Regulations | World Markets
      New Novel Food Regulation: An Overview

      New Novel Food Regulation: An Overview

      Industry reaction has been generally positive, some questions remain.
      By Joerg Gruenwald, analyze & realize ag 09.10.18

    • Bone & Joint Health | Diabetes & Blood Sugar Management | Herbs & Botanicals | Men's Health | Mood Health & Sleep | Quality & Safety | Research | Sports Nutrition
      Botanical Research: Herbal Efficacy & Testing

      Botanical Research: Herbal Efficacy & Testing

      AHPA compiles recent research on botanicals and plant compounds published in peer-reviewed journals.
      By Holly E. Johnson, PhD, American Herbal Products Association (AHPA) 09.10.18

    • Dietary Supplements | Herbs & Botanicals | Medical Nutrition | Regulations
      Confusion Over Cannabis & The Fate of CBD

      Confusion Over Cannabis & The Fate of CBD

      Fair and reasonable or not, FDA could very well be a major buzzkill in the CBD supplement sector.
      By Erik Goldman, Holistic Primary Care 07.02.18

    Breaking News
    • Health Drives Surge in Alternative, Plant-Based Product Options
    • PepsiCo to Acquire CytoSport from Hormel Foods
    • Study Shows Collagen Peptides Aid Runners in Injury Recovery
    • Glanbia Nutritionals to Acquire Watson
    • Alkemist Labs Cuts Testing Turnaround Time by 20%
    View Breaking News >
    CURRENT ISSUE

    Jan/Feb 2019

    • Fiber Revisited: Closing the Gap
    • Green Power for Future Generations
    • Healthy Snacking: Matching Lifestyle with Nutrition
    • Vitamins & Minerals: Traditions in Preventive Health
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • privacy policy
    • term and condition
    • about us
    • contact us

    follow us

    Subscribe

    magazines

    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image

    Copyright © 2019 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login