GMP FDA 21 CFR 110 & 21 CFR 111

21 CFR Part 110 & 111

GMP Requirments for Food & Dietary Supplement Manufactures

Code of Federal Regulations 21 CFR Part 110 requirements for Current food good manufacturing practices (GMPs) describe the methods, equipment, facilities, and controls for producing processed food.

As the minimum sanitary and processing requirements for producing safe and wholesome food, they are an important part of regulatory control over the safety of the nation's food supply.


FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering "conventional" foods and drug products.

Code of Federal Regulations 21 CFR Part 111 all domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, distribution must comply with the above rule for Dietary Supplement Current Good Manufacturing Practices if marketed in US.


Post 2016 FDA more serious and alert on CGMP regulations on nutraceutical / food supplements. If you are a small or large dietary supplement manufacturer, you need to comply with FDA 21 CFR 111 regulation strictly and ready to face FDA inspection.

I 3 CONSULTING team is strong enough to guide organizations with top quality of technical expertice and deliverables in the following ....

  • US FDA 21 CFR 110 and 21 CFR 111 Guidance and Compliance consulting on Facility, Infrastructure, Manufacturing, Quality Control & Documentation
  • US FDA 21 CFR Part 111 Pre Inspection / Audit.
  • US FDA 21 CFR Part 111 Post Inspection Consultation.
  • US FDA 21 CFR Part 111 Post Inspection 483 Response preparation and submission.
  • US FDA 21 CFR Part 111 483 Response, Support in closing CAPA and Follow up with USFDA.

21 CER 110 & 111 compliance Consultation Services and Fees

  • Option 01: Regular Service for 21 CFR 111 Implementation at your factory
  • Option 02: FDA Pre Inspection GAP Analysis and Guidance (500 USD/man-day + Travel + Accommodation)
  • Option 03: Closing of 483’s (500 USD /483)

All domestic and foreign manufacturing facilities selling their food articles for consumption in US should register with FDA.

Food Facility Registration;

Good Manufacturing Practice;

Note: Option 02 Consultants will be travelling from nearest office location [Chicago, USA or Cologne, Germany or Bangalore, India]

Kindly contact us to know, how we can help you and applicable fee.

Recent Review

Mr. Karz Cob Reviewed and commented on . Thanks for support in 21 CFR Part 110 & 111. Thanks for your valuable services and support. Appreciated Rating: 4.9

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