Top Two FDA Observations in Dietary Supplement Manufacturing: How to Avoid Them
Common 21 CFR Part 111 Compliance Challenges in Supplement Manufacturing
Regulatory compliance in the dietary supplement industry can be a challenge and it appears to be growing. While the number of food industry FDA Form 483s declined from 2023 to 2024, there was a 46% increase in 21 CFR Part 111 observations. There were 1,083 observations in 2023 and then 1,578 in 2024, putting dietary supplement brands and manufacturers in a difficult position.
At cGMP Consulting Inc., we have worked with numerous dietary supplement manufacturers, helping them remedy and respond to these and other FDA findings. The two most common FDA observations in 2023 and 2024 reflect both inspection data and the real-world issues our clients have brought to us.
In this article, we break down these top two observations and provide practical, actionable strategies to help manufacturers avoid them. By understanding these challenges, manufacturers can enhance cGMP compliance, product quality, and regulatory readiness, thereby avoiding these same issues for their organization.
Observation #1: Lack of Product Specifications for Finished Dietary Supplements
Regulatory Reference: 21 CFR 111.70(e)
FDA’s Most Frequent Observation:
“Product specifications for the identity, purity, strength, and composition of the finished dietary supplement were not established.”
This has been the top FDA observation in both 2023 and 2024, indicating that many manufacturers are failing to set clear and compliant product specifications that meet the expectations of the FDA.
How to Prevent This Issue:
- Establish Written Specifications – Define specifications for identity, purity, strength, and composition of all finished products.
- Implement Comprehensive Testing – Conduct finished product testing with a qualified laboratory for correct ingredient disclosure and support any nutrition or health claims on the label.
- Maintain Thorough Documentation – Keep detailed records of specifications and testing procedures as part of your Quality Management System (QMS).
- Conduct Regular Internal Audits – Ensure specifications remain up to date and are compliant with regulatory standards.
Observation #2: Lack of Identity Specifications for Each Component
Regulatory Reference: 21 CFR 111.70(b)(1)
FDA’s Most Notable Observation in 2024:
“You did not establish an identity specification for each component.”
This violation was observed 66 times in 2024, up from zero occurrences in 2023, signaling an increased FDA enforcement focus on component identity testing.
How to Prevent This Issue:
- Set Identity Specifications for All Ingredients – Ensure every ingredient has defined identity specifications, in addition to visual or organoleptic, before use in manufacturing. With the growing demand for unique and exotic ingredients, ensuring compliance, specifically identity, has become more challenging than ever.
- Verify Component Identity – Implement validated identity testing methods such as HPLC, FTIR, Mass Spectroscopy, or DNA, etc. Acceptable methods vary based on the component; different ingredients will likely require different tests.
- Supplier Qualification Program – Require detailed Certificates of Analysis (COAs) and verify supplier testing methods. Supplier audits should be conducted. Ingredient sources need to be traceable in the event of an adverse event or a recall.
- Regular Training – Educate teams on identity specification requirements and seek outside expertise as needed to fill in the gaps.
How cGMP Consulting Supports Supplement Manufacturing Compliance
Adhering to dietary supplement regulations can be resource challenging, but cGMP Consulting provides the expertise and support you need to ensure compliance and avoid resource-intensive FDA observations. Our team understands the intricacies of 21 CFR Part 111 compliance, helping manufacturers strengthen their quality systems and regulatory readiness.
Our Services:
Auditing Services
- Depending on your needs, we can conduct Gap Assessments, Internal Audits & External Audits that:
- Identify non-compliance areas and recommend corrective actions
- Provide third-party insights and share industry best practices
Quality Management System (QMS) Development
- Build customized QMS solutions that meet FDA cGMP regulations while aligning with your operational needs
Technical Writing & SOP Development
- Develop clear, regulatory-compliant Standard Operating Procedures (SOPs) tailored to your facility’s unique processes
- Our technical writers understand the regulations and can customize for your unique operational demands
Compliance Training Courses
- cGMP Training: Teach your team, new hires to experienced, how to implement and maintain 21 CFR Part 111 compliance
- Audit & Inspection Readiness: Prepare for FDA and supplier audits through mock inspections
GMP Certification
- We are ISO 17020 accredited, offering GMP certification to enhance market credibility and access for qualified auditees.
Find and remedy your compliance gaps before the FDA does. Contact us today to discuss how we may be able to help you avoid these common but difficult issues.
