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Domestic and Foreign Factory Inspections

FDA inspections can go smoothly or take you into a world of fear and trembling. Your inspection starts before the FDA shows up at your door.  The onsite inspection looks for examples of your regulatory failures.  Your inspection remains open after the FDA goes out the door.  Once you understand how an inspection is conducted and its purpose, you can develop a quality assurance plan that relieves or mitigates problems with the FDA.   It comes down to the phrase, “An ounce of prevention is worth a pound of cure.”  

Encore Insight LLC’s work will cover issues such as Corrective and Preventive Action (CAPA), quality assurance, manufacturing operations, required reporting and how to manage the Form FDA 483.  A 483 is a dreaded list of observations that indicate you fail to comply with various FDA’s requirements.  You also need to the fill in the gaps and smooth out the edges of your current Good Manufacturing Practice (GMP) program and/or your Quality System Regulation (QSR) program.  

Encore Insight offers an ex-FDA senior manager’s experience that started his career as an FDA investigator and conducted factory inspections and investigations.  Many of his inspections resulted in extensive 483s, Warning Letters, Seizures, Injunctions and litigation.  You can reap the benefit of his experience rather than live in fear of enforcement actions that may loom in your future.  

Encore Insight also offers an in-person seminar on the FDA’s inspection program.  You will learn how to prepare for an inspection, how to manage an inspection and how to respond to the FDA.  An inadequate response to a 483 or Warning Letter can dig the hole deeper.  That’s not a good thing.

  

 
  More Information

Quarterly Blog: Cap's Twist on the FDA


Contact Encore Insight

Encore Insight LLC
Casper E. Uldriks

1678 West Harbour Towne Circle
Muskegon, MI 49441
casper.uldriks@gmail.com
Tel: (202) 664-2077
Fax: (202) 733-1674
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