There is a growing concern in the Dietary Supplement industry that the new re-inspection fees mandated under the Food Safety Modernization Act (“FSMA”) could be a hardship on an already aggressively regulated industry. In 2007, the FDA issued current Good Manufacturing Practices (cGMPs) for dietary supplements, a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. The FDA enforces these requirements by performing cGMP inspections at facility sites. Since their inception, the number of cGMP inspections have increased each year. So far, 2011 has nearly 20 times more inspections than what was performed in 2008, according to FDA data and an article on Nutra Ingredients-USA.com.
If FDA conducts a cGMP inspection and records its observations on Form 483 as “Official Action Indicated”, or “OAI”, it could begin assessing the FSMA re-inspection fees almost immediately when it returns to determine whether its observations have been properly addressed. These fees would more than likely drive costs up for the manufacturer, and in turn for the consumer of dietary supplements as well.
The warning letters continue as the FDA vows to maintain cGMP vigilance with inspections (see article from Nutra Ingredients-USA.com). It is clear that the dietary supplement industry will need to have stricter procedures in place to ensure they have thoroughly covered everything under FDA’s cGMP requirements. Otherwise, re-inspection fees, as well as other penalties, could arise from non-compliance.
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