US FDA Pre-inspection Facility And Documentation Gap Assessment

The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Unlike prescription drugs, dietary supplements do not require FDA pre-approval before marketing, but they are subject to postmarket enforcement.

I3CGLOBAL brings unmatched expertise in helping dietary supplement manufacturers comply with FDA’s 21 CFR Part 111 requirements. With over two decades of hands-on experience, our regulatory consultants guide clients through the complexities of Current Good Manufacturing Practices (CGMP), ensuring full compliance in documentation, quality systems, production processes, and facility readiness. We provide end-to-end support tailored to meet FDA expectations. Whether preparing for inspections or strengthening internal systems, I3CGLOBAL is your trusted compliance partner

Transcript

1. FACILITY AND DOCUMENTATION GAP ASSESSMENT US FDA PRE-INSPECTION Food / Dietary Supplements AS PER FDA 21 CFR 111 Regulation
2. The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Unlike prescription drugs, dietary supplements do not require FDA pre-approval before marketing, but they are subject to post- market enforcement. How Dietary Supplements Are Controlled by the FDA (as of 2025) w w w . i 3 c g l o b a l . c o m
3. 21 CFR 111 An Overview 21 CFR 111 refers to the regulations set by the U.S. Food and Drug Administration (FDA) governing the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements/food supplements or Neutraceuticals. These regulations ensure the quality and safety of nutritional supplements by outlining how they should be manufactured, prepared, labelled, packaged, and stored. Here’s an overview of its key elements: w w w . i 3 c g l o b a l . c o m
4. Our Expertise I3CGLOBAL brings unmatched expertise in helping dietary supplement manufacturers comply with FDA’s 21 CFR Part 111 requirements. With over two decades of hands-on experience, our regulatory consultants guide clients through the complexities of Current Good Manufacturing Practices (CGMP), ensuring full compliance in documentation, quality systems, production processes, and facility readiness. We provide end-to-end support tailored to meet FDA expectations. Whether preparing for inspections or strengthening internal systems, I3CGLOBAL is your trusted compliance partner. 3000+ FDA REGISTERD FACILITIES 75+ TECHNICAL STAFF 1999 STARTED w w w . i 3 c g l o b a l . c o m
5. 21 CFR 111 Focus areas(1) 111.1 – Who is subject: Applies to any person who manufactures, packages, labels, or holds dietary supplements for U.S. distribution. 111.3 – Definitions: Important definitions like quality, component, batch, etc. 111.8: Personnel must be qualified through education, training, or experience. 111.10: Hygienic practices must be followed to prevent contamination. 111.12: Supervisors must be qualified to oversee operations. 111.15: Sanitary conditions, pest control, maintenance of facilities, and equipment sanitation. 111.25: Equipment must be designed and maintained to prevent contamination. 111.27: Cleaning and maintenance of equipment. w w w . i 3 c g l o b a l . c o m
6. w w w . i 3 c g l o b a l . c o m 111.55 – 111.75: Establish procedures to ensure the dietary supplement is manufactured to meet quality standards. 111.70: Establish specifications for raw materials, in-process controls, finished products, packaging, and labeling. 111.73: Reject substandard components. 111.75: Ensure specifications are met using testing and examinations. 111.105 – 111.117: Quality control operations, including oversight, review, and approval/rejection of processes and products. 111.153 – 111.170: Handling of raw materials, packaging components, and labels; quarantine, inspection, and disposition. 111.205 – 111.210: Requirement to prepare and maintain a written MMR for each unique formulation and batch size. 21 CFR 111 Focus areas(2)
7. 111.255 – 111.260: Create and maintain a BPR for each batch produced, documenting each step. 111.303 – 111.320: Ensure lab tests are scientifically valid; lab personnel must be qualified. 111.365 – 111.430: Covers all stages of manufacturing, including material handling, equipment use, and process monitoring. 111.403 – 111.415: Ensure correct labeling and prevent mix-ups during packaging. 111.453 – 111.475: Conditions for storing and distributing dietary supplements to prevent contamination and mix-ups. 111.503 – 111.570: Handling of returned dietary supplements, including evaluation and disposition. 111.553 – 111.570: Procedure for receiving, reviewing, and investigating product complaints. w w w . i 3 c g l o b a l . c o m 21 CFR 111 Focus areas(3)
8. Meet Team India SOIO GEORGE BEENA SATISH ARUN FRANCIS Lead Auditor and GMP Expert 26 Years Experience Lead Auditor and GMP Expert 22 Years Experience Lead Auditor and QMS Expert 16 Years Experience w w w . i 3 c g l o b a l . c o m
9. Fee Soio George: $1,500 for the first man-day, and $1,000 for each subsequent day. Beena Satish: $1,200 for the first man-day, and $800 for each subsequent day. Arun Francis: $1,000 for the first man-day, and $600 for each subsequent day. A man-day is considered as 6 to 7 hours of working time, with a maximum of 12 hours including travel. All charges in USD will be converted to INR at the prevailing exchange rate, and GST will be added extra as applicable. w w w . i 3 c g l o b a l . c o m
10. OUR CUSTOMERS w w w . i 3 c g l o b a l . c o m
11. Have questions? Need expert support? We're here to help you achieve FDA regulatory compliance before FDA inspection Reach out to our team today. GET IN TOUCH! +91 80 50648432 enquiry@i3cglobal.com Number Phone E-Mail Bangalore, India Address @i3cglobal.com website w w w . i 3 c g l o b a l . c o m
12. YOU!! THANK w w w . i 3 c g l o b a l . c o m