21 CFR 110 & 21 CFR 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. Read More>>

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. Read More>>

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 of hard core regulatory professionals well over 12 to 22 years of international experience in US FDA 21 CFR 211 compliance consulting for OTC & Generic drugs. Our compliance service includes 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.

Contact them to discuss your needs in meeting FDA compliance in any of the following

  • 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)

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.

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

Good Manufacturing Practice (GMP)

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