HBW Insight 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


Supplement GMP Documentation Better, But Still No. 2 On FDA Observation List – AHPA

Executive Summary

FDA revisits about a third of supplement manufacturing sites, with two-thirds coming within three years, says AHPA. Chief information analyst Merle Zimmermann says FDA increased focus on recordkeeping has resulted in an improvement and fewer problems reported since 2015

You may also be interested in...

FDA Raps Supplement Maker Marco Pharma For GMP Violations Surfaced During Inspection

The US Food and Drug Administration directs Marco Pharma International to correct GMP compliance issues identified during a May 2019 site inspection, including quality control and recordkeeping failures, in a warning letter made public 4 February.

Sea&Ski Sunscreen Firm Warned About GMP Violations, Acne, Eczema Claims

Cross Brands violated GMP including verifying the identity of ingredients and made acne- and eczema-treatment label claims for products not covered under the OTC drug monograph, says FDA in a warning letter.

FDA Combines Supplement GMP Recordkeeping, Testing Waiver Estimates

FDA didn't change its estimates for industry's annual regulatory burden – 929,140 hours – from compliance with recordkeeping requirements in supplement GMPs, its estimates of eight hours needed to prepare a request for exemption from identity-testing requirement also in unchanged.

Related Content





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