Registrar Corp is offering Virtual Inspection Preparation Assistance during COVID-19.
When you register with the U.S. Food and Drug Administration (FDA), you consent to an FDA inspection at any time. FDA may choose to conduct a routine inspection of a facility. In addition, FDA may also inspect any U.S. importer for Foreign Supplier Verification Program (FSVP) compliance of each food and beverage product from foreign suppliers.
Registrar Corp can dispatch a Food Safety Specialist to help your facility prepare for an FDA inspection.
What can you expect from an upcoming inspection?
Assesses the following during a 2-5 day period:
- FDA-registered food facilities must follow Current Good Manufacturing Practices (CGMPs) that address aspects such as:
- Employee Hygiene and Training
- Plant Construction and Design
- Cleaning and Sanitation Procedures
- Raw Materials & Ingredients
- Manufacturing Operations
- The Preventive Controls rules require facilities to implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) plans, which include aspects such as:
- An analysis of known and reasonably foreseeable food hazards
- Preventive controls for identified hazards
- Adequate monitoring procedures for preventive controls
- Supply-Chain Program
- Recall Plan
FDA is authorized to collect FSVP records and other relevant information during an FSVP inspection. The information requested can be associated to the following, as applicable:
- Eligibility for very small importers (i.e., financial records, calculations, etc.)
- Determination that a food product is within the scope, under the regulatory oversight and in compliance with the food safety requirements of a country that has an agreement with FDA
- Evaluation of the foreign supplier for approval (i.e., supplier performance and risk posed by the food)
- Hazard Analysis of the food
- Determination and conduct of verification activities
- Supplier written assurances
- Corrective actions taken when food safety issues were discovered, if applicable
- Written procedures for conducting FSVP-related activities
- FSVP supporting documents (e.g., product descriptions/specifications, labels, supplier's food safety plan, food safety records, testing and/or audit reports, etc.)
- A Qualified Individual's merits
- And more...
Registrar Corp Makes Compliance Easy
Registrar Corp can dispatch a Food Safety Specialist to help you prepare for an FDA inspection.
A Mock FDA Food Facility Inspection includes:
A complete review of your food safety documentation
A thorough assessment of your facility's compliance with regulatory requirements
Virtual or onsite expert assistance from a Food Safety Specialist
A Mock FSVP Inspection includes:
Review of all FSVP documentation
Assessment of documentation identification of incomplete, inaccurate or missing documents
Virtual expert assistance from Food Safety Specialist
