Good Manufacturing Practice

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue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FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue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The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good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...

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