Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


GMP Documentation, Identity Testing Continue To Trip Supplement Firms

This article was originally published in The Tan Sheet

Executive Summary

Warnings from FDA's Office of Regulatory Affairs make clear that failing to document compliance with each GMP requirement renders those parts of the process noncompliant. Warning letters posted March 22 also include FDA's latest enforcement against firms marketing bulk caffeine.

You may also be interested in...

Supplement Own-Labeler’s GMP Stumble Reveals AER Slip

FDA warns own-labelers ProSupps USA and Cape Fear Naturals about GMP violations, also pointing out ProSupps dropped the ball on submitting serious AERs to FDA and Cape Fear Naturals made drug claims including “improve blood pressure and cholesterol.”

FDA Says Take Note: Document Supplement GMP Corrections

FDA's latest supplement GMP warnings once again demonstrate the importance of appropriate documentation during manufacturing and in responding to questions from agency inspectors.

FDA Takes The Measure Of Bulk Caffeine In Warnings About Labels

Serving amounts such as one-sixteenth of a teaspoon indicated on product labels “cannot be accurately measured using common household measuring tools,” FDA says. NPA, however, suggests the agency gives too little credit to consumers’ measuring skills.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts