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21 CFR Part 111

21 CFR Part 111 Importance

21 CFR Part 111 applies to good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. We are the US FDA consultants supporting food supplement manufacturers to implement CFR 111.


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, labeling, and warehousing of dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S.A

21 CFR Part 111 Implementation Timeline

21 CFR Part 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.

Documentation required as part of Implementation

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.

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 Part 111 requirements.

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

The I3CGLOBAL team has successfully supported hundreds of companies across the globe in this gesture by providing technical solutions such as:

European Free Sale Certificate

21 CFR Part 111 Fee

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

  • 21 CFR Part 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.