Wednesday, December 20, 2017

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).

1 comment:

  1. Wine kills pathogens and there is no history of food safety issues in wineries. Pathogens are not sustainable in beer also. Forcing food based GMP's (Government Manufacturing Practices)(nothing Good about them pertaining to alcoholic beverages) is ridiculous. Especially anyone looking at their craft holistically with microbial diversity being a goal. This crazy nonsense somehow got skipped in the exemptions in sec 116 in the FSMA. Almost makes the exemptions moot. This is ridiculous unnecessary over regulation.

    ReplyDelete