CGMP Inspections are happening! The FDA has a target of 500 inspections in FY18.
In the Northeast and New England inspections will be performed by the FDA. Mills in Pennsylvania can expect inspections through PDA but they could be observed by an FDA investigator. Expect the inspection to take several hours, even the better part of a full day.
Inspection Observation: I would appreciate the opportunity to observe your inspection. In the rare case when the inspection is scheduled, please call me if you are willing to allow me to participate as an observer. If it is not announced in advance (more likely) and you are in close proximity to CFD (Conklin NY), please call me at 607-759-4175. I will drop everything to get there as soon as possible. In all cases, please call me to talk about your experience after the inspection is complete. As an industry we should come together and your experience can be a learning tool for others.
Speaking of Industry Cooperation – There is still time to participate in the Independent Salmonella Study…