FSVP Inspection Results & Trends, 2018

Where are importers falling short? Enforcement of FSVP has reached its 1 year anniversary and stats were shared at the Annual AFDO Conference by Sharon Lindan Mayl, JD, Senior Advisor for Policy at the Office of Foods and Veterinary Medicine, Food and Drug Administration. Below is a brief account:

BACKGROUND

The FSVP implementation program was initiated in June 2017. Inspection have been pre-announced, with a focus on evaluating FSVP importers’ compliance with the FSVP requirements, consistent with PC inspections for supply chain provisions.

The data set below indicates the number of actions indicated during FDA inspections of importers, from June 2017 to May 2018:

 NOTE: 483a forms (i.e. FSVP Observations) were given to 174 of 179 VAIs in 2017, and all VAIs of 2018.

NOTE: 483a forms (i.e. FSVP Observations) were given to 174 of 179 VAIs in 2017, and all VAIs of 2018.

TRENDS

The trends are encouraging for industry but also a reminder of the consequence of failing to comply:

  • A significant decrease in NAI (≅25%) and VAI (≅20%)
  • A slight increase in VAI and slight decrease of NAI, as a percentage of action taken (≅1%, respectively) 
  • No OAI (0)
  • Significant decline (≅22%) of any action indicated.

SIGNIFICANT OBSERVATIONS

483a forms (i.e. FSVP Observations) have been written for the following reasons:

  • Failure to have any FSVP
  • Failure to establish written procedures to ensure that foods are imported only from approved foreign suppliers
  • Failure to have a written analysis to identify and evaluation known or reasonably foreseeable hazards.
  • Failure to document the approval of foreign suppliers
  • Incorrect entry data

WHO IS NOT INCLUDED IN THIS DATA?

The majority of the data represents enforcement activities related to importers importing food from large farms (>$500k in annual produce sales during the previous 3-year period) and large, registered food facilities (>500 full time employees) and excludes very small importers.

Importers, importing food from foreign suppliers subject to Preventive Controls (PC) or Produce Safety (PS) regulations, are required to comply with FSVP 6 months after the applicable PC or PS compliance date. For compliance dates, check out FDA’s compliance date chart below! If you have any questions or would like to discuss FSVP compliance, contact us!

-MK

**Correction: There have been no warning letters given in FSVP inspections, only significant observations (483a forms).

Screen Shot 2018-06-24 at 9.07.52 PM.png