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FDA Requires Responses to Inspection Requests within 24 Hours, According to New Inspection Refusal Guidance

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance that outlines their interpretation of the term “refusal of inspection.”  According to the guidance, FDA requires food facilities receiving notice of FDA inspection to confirm acceptance of the inspection within 24 hours. Failure to confirm within 24 hours may be deemed refusal of inspection, resulting in refusal of that facility’s future food shipments to the US.  Further, any attempts to limit or condition the inspection in any way likewise may be deemed a refusal of inspection, with the same harsh consequences.

What are the Consequences of Being Deemed a Refusal?

Facilities that refuse inspection are placed under Import Alert 99-32, and their food articles face refusal of admission at the port of U.S. entry.  In addition, their FDA registration may be suspended.

How Can I Prevent Being Deemed a Refusal?

The recent guidance amplifies the importance of understanding FDA’s expectations for the inspection process and having a reliable U.S. Agent as a guide.  Before the inspection begins, the Agency may interpret actions such as not agreeing to an inspection start date or rescheduling an inspection without reasonable explanation as attempts to circumvent the inspection.  Upon receiving a notice of inspection, a facility should work with their U.S. Agent to respond to FDA promptly and cooperatively.

During the inspection, a facility should maintain this cooperation with the FDA inspector.  Any attempts to interfere with or delay the inspection, such as limiting the inspector’s observations to certain areas of the plant or omitting requested documents, may constitute refusal.  Facilities should ensure that they accommodate the inspector’s requests and refrain from any actions that might limit a full observation of daily operations.

Our Facility Is Under Import Alert for Inspection Refusal.  What Can We Do?

To seek removal from the Import Alert 99-32 Red List, a facility must petition for inspection by FDA.  The guidance states that for some facilities, scheduling an inspection after an initial refusal may take at least one year.  Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.

Proper guidance from a third party experienced in FDA regulations can prove invaluable to a facility facing inspection.  Registrar Corp’s trained Regulatory Specialists are knowledgeable in FDA inspections and can conduct a Mock FDA Inspection of your facility.  Our experts can help identify potential food safety issues to fix before an inspection and educate facility staff on FDA expectations. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Registrar Corp can act as your U.S. Agent to help you promptly schedule inspection with FDA, as well as provide your facility a host of additional benefits, including biennial registration, detention assistance, and compliance monitoring.