Wineries Begin Seeing Surprise FDA Inspections as Part of FSMA

Many firms are seeing FDA inspections for the first time as the FSMA regulations are coming into effect, including wineries.  An article in Wine Business Magazine (December, 2017) indicates that a number of wineries are undergoing surprise FDA inspections.  For many, this may be a new experience.

From the article, "New registration and record keeping requirements for wineries under FSMA impose important changes. Wineries must now renew their FDA registration every two years.."  Wineries must also comply with GMP requirements, including the need to have documented employee training.  These firms are exempt from the the risk based preventive controls (Subpart C) and the supply chain program (Subpart G).