Quality & Safety: Good Manufacturing Practices (GMP)
Intensive Nutrition Inc. and Intensive Nutrition supplements are fully compliant with all FDA cGMP regulations 21 CFR 111 & 117.
Intensive Nutrition dietary supplements are manufactured domestically by third party, accredited and certified dietary supplement manufacturers in accordance with cGMP and FDA regulations (21 CFR 111 & 117). Additionally, as an "own-label distributor", Intensive Nutrition is licensed by both the California Department of Health and the US Food and Drug Administration.
California License number is 22450.
US Food and Drug Administration Facility Registration number is 14173270938.
How does Intensive Nutrition meet FDA requirements and ensure safety and quality in its products?
Contrary to what you might have read, dietary supplements are regulated by the FDA. In accordance with the 1994 DSHEA ACT and FDA 21 CFR 111 and 117, all dietary supplement companies in the United States must establish cGMP (Current Good manufacturing protocols) to ensure the quality and safety of their supplements. Well implemented cGMP procedures satisfy health and safety requirements and boost consumer confidence.
Intensive Nutrition fulfills its regulatory obligation to ensure safe and high quality supplements in the following ways:
1. Confirm and Verify cGMP
Intensive Nutrition partners with domestic, GMP certified/accredited manufacturers to produce our supplements. We audit our partners to ensure proper protocols are established, met and proper documentation is in hand for inspection and verification.
Example: We will review batch records to ensure that GMP procedures are met such as in-process checking during manufacturing, verification of capsule or tablet weight and so on.
Our dietary supplements, from start to finish, must be tested for the following parameters: identity, strength, purity, composition and presence of contaminants. That testing responsiblity lies with our manufacturing partners but ALSO with us. We must verify that GMP procedures have been completed and that appropriate testing has also been completed by our partners and then confirm that all tests are accurate, utilizing confirmatory testing or other methods.
Essentially, our supplements must be safe for consumption and must meet label claim --- what you read on the label is what you're getting in your supplement. Intensive Nutrition products are: 1) Fully cGMP compliant 2) Meet all quality standards 3) Meet all label claims.
Intensive Nutrition stands by all its products and makes sure you are getting 100% what you've paid for. Period.
Question: What about your 2014 Warning letter? Answer: It has been addressed and violations fixed.
In 2014, we received a warning letter from the FDA regarding improper implementation of cGMP procedures in our manufacturing facility. As a small, family owned concern, we realized that we needed to engage professional assistance to help us properly implement cGMP procedures. With the help of reknown EAS Consulting and guidance from attorneys specializing in FDA and dietary supplements regulatory matters, Intensive Nutrition met regulatory and compliance standards.
Today, we are completely aligned with third party, GMP certified and fully accredited domestic partners to manufacture our dietary supplements. Please email our President, Olivia Melaugh, with any questions. She is happy to answer any and all questions about our GMP compliance.
Consumers should always ask...
As a consumer, you should be able to ask the following questions and receive answers from the supplement manufacturer of your choice.
1) Are your products produced in accordance with cGMP laws as dictated by 21 CFR 111 and 117?
2) Do you have documentation or do you verfiy that your products are being produced in accordance with cGMP?
3) What kind of testing do you perform on your supplements*?
*All finished products should be tested for: Identity, Purity, Strength, Composition and Contaminants. If you are buying your supplements in California, you should ask if the dietary supplement manufacturer is compliant with Proposition 65 regulations. Both a manufacturer and own label distributor (someone who has their products manufactured by a third party), are responsible to ensure all cGMP regulations are met.
Questions? Contact Us.
We are happy to answer any questions you may have about our company, our products and our cGMP procedures.