Attorney at Law in NJ 1971 - 2006 / NJ Notary Public #2398815
Services for Contract Manufacturers
The FDA's new emphasis on the legal obligations of label-owners is of special concern to "private label" contract manufacturers. Your private label clients, including start-up and established vitamin distributors, physicians, chiropractors and other health care providers, are now mandated by FDA to be "in a state of control" over the entire product process. This includes:
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Sher Komisar: 914-966-8053 [email protected] Program Investment Cost: Click Here 1. Sourcing raw materials 2. Manufacturing the bulk product 3. Encapsulating, bottling and labeling 4. Fulfillment 5. Customer Service and Returns. |
5.10.13 -- FDA warning letter: obligations of private label distributors
A new FDA warning letter outlines the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’. http://www.nutraingredients-usa.com/Regulation/FDA-warning-letter-highlights-obligations-of-private-label-distributors Member Entry Click Here |
How will your private label distributors meet this new mandate? With your help, and to your profit!
The Regulatory Compliance Network offers a full suite of third party services to assure your clients that they, and you, will be in full compliance.
We would be pleased to discuss these special services for contract manufacturers with you. We can make it affordable for your company to offer Regulatory Compliance Services to all your private label clients.
Through our third-party certification process you can provide the Documentation, Training and Certification expected by FDA.
Contact us to find out. [email protected] with "Private Label" in the subject line.
More Information: www.RegulatoryComplianceNetwork.com
Says FDA - "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained." Federal Register, page 34811
The Regulatory Compliance Network offers a full suite of third party services to assure your clients that they, and you, will be in full compliance.
We would be pleased to discuss these special services for contract manufacturers with you. We can make it affordable for your company to offer Regulatory Compliance Services to all your private label clients.
Through our third-party certification process you can provide the Documentation, Training and Certification expected by FDA.
Contact us to find out. [email protected] with "Private Label" in the subject line.
More Information: www.RegulatoryComplianceNetwork.com
Says FDA - "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained." Federal Register, page 34811
