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21 CFR Part 111

21 CFR 111

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:

 

Exclusions: 21 CFR 111 does not cover dietary supplement advertising or claims (medicinal claims), which fall under the FTC or Drugs

 

21 CFR part 111 is for those involved in manufacturing, packing, or holding human food supplements. The regulation must be followed by all domestic and foreign companies involved in the manufacturing, testing, packaging, labelling, and warehousing of dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S.A. We are the US FDA consultants supporting food supplement manufacturers to implement 21 CFR 111.

Why is 21 CFR Part 111 Important?

It ensures consumer safety and confidence in dietary supplements while standardizing manufacturing practices across the industry. Compliance not only protects public health but also shields manufacturers from regulatory actions.

The I3CGLOBAL team has successfully supported hundreds of companies across the globe in this gesture by providing excellent implementation support and or Pre and Post FDA inspection support

21 CFR 111 Implementation Timeline

21 CFR 111 will generally take 3–4 months, but there are various factors that determine the time line, including the following:

  1. Types of products manufactured
  2. Number of products manufactured in the same facility
  3. Shop floor area
  4. Technical skills and understanding capabilities of employees
  5. Equipment and utensils used
  6. Air handling system
  7. Shop-floor layout
  8. Disposal of waste, etc.

21 CFR 111 Documentation Requirements

Yes. The organization should maintain the following important documents:

  1. Quality Manual
  2. Mandatory Procedures
  3. Standard Operating Procedures
  4. Validation protocols and records
  5. Batch Manufacturing Records
  6. Quality Plans
  7. Test reports, etc.
Consequences of 21 CFR Part 111 Non-Compliance during FDA Onsite Inspection

Failure to comply with 21 CFR Part 111 may result in:

  • FDA warning letters.
  • Product recalls.
  • Seizures, fines, or legal actions.
Why I3CGLOBAL should be preferred for FDA Pre-Inspection Support?

Generally, the FDA informs the owner or operator of the registered facility about the inspection at least two months in advance. Following the intimation, manufacturers and the regulatory team will be in a hurry to make everything align with 21 CFR 111 requirements.

  • Documentation review and guidance
  • Facility Inspection and Guidance
  • Environmental Controls
  • Quality control and quality assurance compliance
  • Batch Tractability and Recall
  • Specifications

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21 CFR Part 111 Pricing

Our consultants are located in Germany, India, and the USA.

  • 21 CFR 111 implementation starts at $4500. Fees depend on the type of products, shop floor area, number of employees, etc.
  • Pre-Inspection: $450 per man-day plus travel and accommodation.
  • Post-inspection service is based on the number of observations. The fees for closing per observation (483) are $1000.