PDF Edition - Dietary Supplement Inspections: A Comprehensive Guide to FDA Focus Areas and Expectations

March 2013
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Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined.

GMP compliance is the FDA’s focus. In addition to warning letters, the agency is filing lawsuits and even seizing product. What’s a supplement manufacturer to do?

Get up to speed — fast.

Take an FDA crash course. How do inspections work? What does the agency expect in document compliance? Which GMP mistakes are most likely to be targeted?

Luckily, help is now at hand.

Dietary Supplement Inspections spells out how to cope with this new era of enforcement, with tips and how to-strategies to prepare for inspections and avoid GMP violations cited in 483s and warning letters.

It provides an overview of essential references you must understand to cope with tough new levels of FDA scrutiny, plus specifics including:

  • How to avoid commonest GMP violations cited in 483s and warning letters
  • How to prepare for inspections
  • Inspection hot-spots — areas the FDA is likely to scrutinize most closely
  • How FDA inspections will change in coming years
  • And muchmore

Dietary Supplement Inspections originated as an FDANews webinar featuring Dean Cirotta, President and COO of EAS Consulting Group, and William Ment, Senior Advisor to EAS Consulting Group:

  • Mr. Cirotta conducts onsite audits and assessments for clients, helping strengthen their compliance capabilities, and identify and implement corrective actions. He was previously president and COO of UPM Pharmaceuticals and executive vice president-RA/QA for SJ Strategic Investments.
  • Mr. Ment, a contract consultant to EAS, was director of the FDA’s Baltimore District Laboratory in charge of sample analyses and research studies for imported and domestic products, including pharmaceuticals, dietary supplements, in vitro diagnostic devices, microbiological and environmental contaminants and extraneous materials/decomposition in foods.

It’s a new world for supplement manufacturers — a regulated world. You fail to adjust at your peril. Get ready for the FDA investigator beforehe or she knocks on your door.

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