The U.S. Food and Drug Administration (FDA) has the authority to inspect any FDA-registered facility. Facilities located outside the U.S. that refuse an FDA inspection may be placed on Import Alert 99-32, “Detention Without Physical Examination of Products from Firms Refusing FDA Foreign Establishment Inspection”. All products exported to the U.S. by a facility on the Import Alert are subject to Detention Without Physical Examination (DWPE) until FDA is able to inspect the facility.
Import Alerts are public information that can damage a brand’s reputation. Delayed or refused shipments resulting from Import Alerts can also strain relationships with buyers. Thus, it is advised to accept an inspection without hesitation. FDA may issue a Notice of Inspection at any time, so you should prepare by ensuring your facility is compliant with FDA Current Good Manufacturing Practices (CGMPs) and other regulatory requirements.
Food Facility Inspections
FDA requires food facilities to respond to inspection requests within 24 hours. The Agency may interpret a lack of response as refusal of inspection. FDA communicates an inspection request with a facility’s U.S. Agent, so it’s prudent to designate a reliable Agent. When preparing for an inspection, you should familiarize yourself with common inspection violations so you can ensure you don’t make the same mistakes.
We invite you to utilize our webinar recording on how to handle an FDA food facility inspection to help you prepare. For customized preparation assistance, Registrar Corp can dispatch a Food Safety Specialist to your facility to conduct a Mock FDA Inspection. As part of this inspection service, our Specialist will help identify potential food safety problems in the structure, processes, procedures and documentation used in your daily production.
Drug Facility Inspections
There are a variety of actions that FDA may interpret as refusal of a drug facility inspection, including refusing an FDA inspector entrance into a facility, trying to postpone a scheduled inspection date without a reasonable explanation, and more. Registrar Corp’s article on FDA drug facility inspections will help you understand the different types of FDA inspections, how FDA investigators prepare for inspections, and what to expect during an inspection.
Our Facility Is Under Import Alert for Inspection Refusal. What Can We Do?
To seek removal from Import Alert 99-32, a facility must petition for inspection by FDA. FDA states that it may be at least a year before FDA can return to inspect a facility that initially refused. Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.
For more information about FDA inspections or Import Alerts, contact Registrar Corp by phone: +1-757-224-0177, email: [email protected], or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.