Two new rules have been completed by the US Food and Drug Administration (FDA).
These rules require food facilities and importers of food and beverages to monitor and document each supplier’s compliance status. The two rules—the Preventive Controls and the Foreign Supplier Verification Program (FSVP)—are part of FDA’s implementation of the Food Safety Modernization Act (FSMA).
Importers that want to participate in FDA’s Voluntary Qualified Importer Program (VQIP) must also monitor their suppliers, as VQIP importers may not import any food subject to an FDA Import Alert or Class I Recall.
To assist the food industry to comply with this new requirement, FDA consulting firm Registrar Corp created the FDA Compliance Monitor. Here is an excerpt from Registrar Corp’s website outlining compliance procedures for these rules:
FDA’s Preventive Controls Rules require registered food facilities to establish, implement, and document a supply-chain program monitoring their suppliers’ FDA compliance status, “including an FDA warning letter or import alert relating to the safety of food and other FDA compliance actions.
FDA’s Foreign Supplier Verification Program (FSVP) rule requires food and beverage importers to conduct and document an evaluation of their foreign suppliers’ FDA compliance status, “including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.”
All users have to do is submit the facility they would like to monitor, and the FDA Compliance Monitor will reveal any FDA Import Alerts, Warning Letters, Import Refusals, or Inspection Classifications pertaining to the facility. Printable reports let users document compliance of monitored facilities per FDA requirements.
Monitoring suppliers can be time-consuming. In order to monitor supplier compliance using FDA’s databases, a user would need to search each individual database for each supplier every time he wanted to purchase from them. The FDA Compliance Monitor simplifies monitoring by aggregating and organizing supplier data into one compliance dashboard. Data within the monitor is consistently updated, and users are e-mailed anytime a change occurs in compliance status of a company being monitored.
New users can sign up for a free 60-day trial. Free trial users can monitor an unlimited number of companies for FDA compliance. No credit card information is required. For those who wish to continue monitoring after the trial, it’s $1.99 a month per monitored facility.
For questions about FDA’s new FSMA rules or the FDA Compliance Monitor, contact +1-757-224-0177, e-mail [email protected], or live help is available 24-hours a day at www.registrarcorp.com/livehelp.