Good Manufacturing Practice

FDA shuts down NY supplement firm

FDA shuts down NY supplement firm

By Hank Schultz

A dietary supplement manufacturer in Long Island, NY has been shut down by the Food and Drug Administration after numerous and repeated violations of GMP standards and labeling laws.

IStock photo.

AHPA's botanical GMPs document ready for field testing

By Hank Schultz

The American Herbal Products Association has issued a version of its ‘botanical GMPs’ document.  Several member companies have stepped forward to field test the recommendations, AHPA president Michael McGuffin said.

GMPs, AERs, and the NY AG’s action: CRN’s Mister on the big issues of the last decade

Steve Mister’s 10 year anniversary as president and CEO of the CRN

GMPs, AERs, and the NY AG’s action: CRN’s Mister on the big issues of the last decade

By Stephen Daniells

The two most positive things to happen to the dietary supplements industry over the last ten years have been GMPs and AERs, says Steve Mister, CEO of the Council for Responsible Nutrition. And what is the most significant negative thing? The NY AG’s action.

UNPA chief agrees with FDA that GMP compliance far from uniform

Dispatches from SupplySide West 2013

UNPA chief agrees with FDA that GMP compliance far from uniform

By Hank Schultz

Adverse event reporting, amphetamine-like substances showing up in products and NDI notifications are all prominent blips on FDA’s radar, said Loren Israelsen, president of the United Natural Products Alliance.

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

Dispatches from AHPA's Botanical Congress

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

By Stephen Daniells

The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good manufacturing...

Special edition: GMPs

Special edition: GMPs

From warning letters to dry labbing, the attention of many is firmly focused on compliance with, and enforcement of, current Good Manufacturing Practices (cGMPs). In this special edition we bring together all the news, views and developments in GMPs from...

Cerebral Health fails FDA GMP inspection

Cerebral Health fails FDA GMP inspection

The US Food and Drug Administration (FDA) has issued a warning letter to Florida-based Cerebral Health, LLC, for failing to comply with Current Good Manufacturing Practice (CGMP).

GMP veteran Carl Reynolds shares ‘483’ learnings

GMP veteran Carl Reynolds shares ‘483’ learnings

By Shane Starling

The highly regarded good manufacturing practices (GMP) expert Carl Reynolds – recently re-hired by the FDA to help it manage GMP reporting – highlighted problems from stray rodent activity to lack of batch data to inappropriate identity testing.

Expo West reflections: post-recession buy-outs and GMP compliance

Expo West reflections: post-recession buy-outs and GMP compliance

By Shane Starling

Private equity firms came in droves to Expo West looking for post-recession bargains, with dietary supplements firm in their sights. A NutraIngredients-USA.com straw poll in the supplements aisles confirmed acquisition offers were as abundant as natural...

The biggest challenges in making GMPs work

The biggest challenges in making GMPs work

Many medium and small dietary supplement companies are still not close to meeting new GMP requirements, despite the looming deadlines. Lorraine Heller speaks to industry members about the major challenges that remain, and the next steps that should be...

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