Gmp Violations

Surging sales, more transparency pressure driving contract manufacturing transformation

16-Apr-2021 By Hank Schultz

Rising demand in the contract manufacturing realm is driving both consolidation and pressure to make more transparent this sometimes closed section of the dietary supplement industry, observers say.

Confidence USA ordered to close after decade of inspection failures

09-Mar-2021 By Hank Schultz

Confidence USA Inc, a dietary supplement manufacturer, has been ordered to close after a history of alleged non-compliance with cGMP regulations that extends over a decade.

ABH recall debacle holds stern lessons for industry, experts say

06-Apr-2020 By Hank Schultz

A wide ranging recall of products made by a New York-based contract manufacturer holds lessons supplement firms can use to avoid similar problems in the future, experts say.

Contract manufacturer recalls products under more than 1,200 brand names

21-Jan-2020 By Hank Schultz

A New York-based contract manufacturer has recalled hundreds of lines of products manufactured over a period of almost seven years in a consent decree it publicized recently.

Lack of adequate counsel when setting up operations can lead to big regulatory headache later

25-Sep-2017 By Hank Schultz

A recent warning letter to a Colorado dietary supplement company illustrates the hot water companies can get themselves into when starting business operations without adequate counsel.

Supplement firm still in operation despite slew of disease claims, GMP violations

04-Nov-2015 By Hank Schultz

A warning letter issued last month to dietary supplement firm Sound Healing Arts illustrates what’s wrong with the current enforcement picture at FDA, says an industry observer.

Supplement maker Kabco shut down over GMP violations

10-Apr-2013 By Hank Schultz

After a history of GMP compliance failures, dietary supplement manaufacturer Kabco Pharmaceuticals has been shut down by FDA until such time that it can meet the stipulations of a consent decree.

NX Generation Ltd. warned for alleged GMP violations

06-Feb-2013 By Stephen DANIELLS

The Food and Drug Administration (FDA) has sent a warning letter to New York based NX Generation Ltd for ‘serious violations’ of the current Good Manufacturing Practice (cGMP) regulation for dietary supplements.

‘We’re gaining market share because of GMPs’: BI chief

28-Mar-2012 By Stephen Daniells

GMP compliance and enforcement is good for the industry, but it is also good for business for suppliers that focus on quality, says George Pontiakos, president and CEO of BI Nutraceuticals.