Tip of the Week: Benefits of a Well Designed Entry Procedure and Facility Registration

In many food facilities around the US, appropriate steps for entering the plant need to be modified to ensure safety and compliance. However, some facilities do not comply with the basic protocols for visitors and regulatory auditors. This makes the facility vulnerable to unauthorized entry, as well as inappropriate conduct by visitors while in the facility.

“These facilities are excellent candidates for the FDA Preparedness Inspection.” said Dr. Cornelius Hugo, Food Safety Professional, North America at AIB International. “This inspection tests old policies as well as new ones brought about by FSMA, such as access to records and employee interviews.”

Hugo said the basic protocol for entering a facility should include:

  • Positive identification of the visitor such as a company-issued photo ID or a government-issued ID
  • Signing the visitor log
  • Date, name, purpose of visit, contact person, and time of entry
  • Review and acknowledgment of expected compliance with basic GMP requirements and additional visitors’ policies, as appropriate, such as:
  • Verbal/written review of policy and signature, or
  • Watching a video of visitors’ policies and signature

If the visitor has identified him or herself as an FDA inspector, authorizing documentation must be presented during the opening meeting, or the entry can be denied. Form 482 is the official FDA document, which represents its authority to conduct the audit activity.

Not all facilities will ask the auditor for Form 482 and the reason for the visit. It is important that these two questions be asked immediately after introductions. The reasons for visiting a facility include routine inspections, for cause, or investigative. If the FDA official does not present Form 482, the facility is well within its rights to refuse entry.

The facility registration provides an inventory of all food manufacturing and distribution facilities, which offer food products for sale in the USA, both domestic and foreign. It came as a result of the terrorist attack of September 11, 2001; which made it imperative to be able to track a potential terrorist attack through the food supply chain and deploy effective countermeasures. 

While most facilities can provide proof of registration, some have difficulties providing sufficient evidence, or have deficiencies in the registration papers. Some of these failures include: not having the official registration document at the facility, not having updated information such as a key contact person, or including part of the facility, such as a warehouse, as a different address that’s part of the facility registration.

This proof of registration needs to be at the site and current. Updates to the registration can only occur every 2 years, on even calendar years, between October 1 and December 31. The registration should include only the buildings located at each specific physical address.

Have a great tip to share when admitting entry to facility inspectors?

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