David Hanlon has had a long and impressive career in the pharmaceutical industry. He has helped various manufacturing sites prepare to meet FDA Compliances. FDA inspections can be disruptive, because most of the time they are unannounced (exception with clinical trial sites and sponsors of clinical investigations). However, they are necessary and if not handled correctly, can impact a business success on many levels. Good preparation and management of the inspection can make the experience less upsetting to the day-to-day business activities.
An adverse consequence from a failed inspection can really harm a company and can range from time cost due to responses to regulatory observations and delayed product launch, to publicly announced Warning Letters or even civil or even criminal litigation by the FDA. Proper preparation can prevent unnecessary harmful consequences.
The FDA conducts inspections for a myriad of reasons including; a routinely scheduled surveillance inspection; a preapproval inspection to decide a products approval; and a “for cause” inspection arising from a product complaint, recall, or information given to the FDA by a whistleblower.
The purpose behind each inspection no matter what the catalyst is to determine if violations of FDA laws are occurring, and if so, try to have the involved entity voluntarily corrected issue without further action.
He has more than 20 years of experience performing manufacturing site transfers and new product scale-up and introduction for sales of over $750+ million annually. He also supervised and had direct involvement in over 100 FDA, European and health agency inspections.
David Hanlon 