Tag Archives: cGMPs

FDA Releases FY2017 Inspection Observations


CFR # Description # Obs.
21 CFR 111.70(e) Specifications – identity, purity, strength, composition 92
21 CFR 111.103 Written procedures – quality control operations 73
21 CFR 111.553 Written procedures – product complaint 63
21 CFR 111.75(c) Specifications met – verify; finished batch 61
21 CFR 111.75(a)(2)(ii)(A) Component – qualify supplier 50
21 CFR 111.205(a) Master manufacturing record – each batch 50
21 CFR 111.255(b) Batch record – complete 47
21 CFR 111.453 Written procedures – holding 46
21 CFR 111.75(a)(1)(i) Component – verify identity, dietary ingredient 45
21 CFR 111.70(b)(2) Specifications-component purity, strength, composition


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.

FDA Releases Partial FY 2016 Inspection Classifications


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.

SupplySide West Workshop: Evaluating and Partnering with Contract Labs


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

See http://west.supplysideshow.com/schedule/#/viewEvent/bb49164ebdcc410ea9b41585fb26bfa4/wrk/day/-1

Sizing up the Dark Side: An overview of the NBJ Dark Issue

Date/Time: March 30, 2016, 2:00pm ET / 12:00 MT

Cost: $95


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:

Steve Mister
Council for Responsible
Todd Harrison
Supplements Lawyer
Risa Schulman
Science Consultant
Marian Boardley
GMP Specialist

Bring questions!

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.

FY2015: Dietary Supplement cGMPs – FDA Inspection Observations

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.

Speaking: Contract Manufacturing Workshop – SupplySide West, Oct 9, 2015


Friday, October 9 

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.


Key Considerations in Selecting and Working with a Contract Manufacturer: How to Audit and Qualify Suppliers for CGMP Compliance 
Recent FDA and other enforcement activities indicate dietary supplement firms are responsible for choosing CGMP-compliant contract manufacturers and suppliers. This session provides simple steps and actions you can take to minimize risk, protect your brand, and prepare you to audit and work in partnership with your suppliers for maximum compliance.

You will learn:

  • Best Practices: Simple, efficient and cost-effective ways to pre-select and audit your contract partners.
  • Quality Agreements: When and why do you need one? What items must be included?
  • Supplier Qualification: Tools for risk assessment and verifying that your label claims are met.
  • Quality Control: How much and which QC operations must you perform before product distribution?


Marian Boardley, principal, Marian Boardley Consulting LLC