The FDA is Here! A Primer on What To Expect - Careful preparation and a cooperative attitude will ensure a more positive inspection experience. - BioPharm International

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The FDA is Here! A Primer on What To Expect
Careful preparation and a cooperative attitude will ensure a more positive inspection experience.


BioPharm International
Volume 18, Issue 8


Gerald E. Vince
No matter how often you experience an FDA inspection, you always get butterflies in your stomach when you hear the phrase, "The FDA is here!" You, as the primary contact person, know what to expect because you have been through numerous regulatory inspections in the past.

Much of your concern is centered on everyone else who may have to meet with or provide information to the FDA investigator(s). Are they prepared and do they know what to expect and how to act? The following article is intended as basic guidance to people who have never experienced a regulatory inspection, as well as a reminder for all of those who have been through the inspection process before.

FDA'S HERE! --- WHY? The agency can inspect a firm for a variety of reasons. Some of the major reasons for an FDA inspection are:

  • General Inspection (Current Good Manufacturing Practices [cGMPs]/Quality Systems Inspection Technique [QSIT])
  • Pre-Approval Inspection
  • Post-Market Follow-up
  • For Cause Inspection (suspected problem, recall, etc.)
  • Sample collection
  • Others (complaint handling, Prescription Drug Marketing Act, etc.)

WHAT HAPPENS FIRST? A plan of action should be outlined in a formally approved standard operating procedure (SOP), which defines who is responsible for performing each duty during the course of an inspection. This SOP should detail actions which may be taken during an inspection in particular situations encountered (e.g., provision of photocopies) as well as other activities outlined here.




In general, the first responsibility is for the receptionist to notify the corporate primary contact and appropriate manager of the FDA personnel's arrival. It is imperative that management and staff who may be impacted are aware that FDA is on the premises. Managers and area supervisors must ensure that all personnel in operational areas are aware that FDA is presently in the facility.

During initial discussions with FDA investigators, the primary contact should check the credentials of FDA personnel, determine the purpose and probable length of the visit, and accept the FDA-482, Notice of Inspection issued by the investigators (or at times, an analyst and/or microbiologist). The contact person should maintain a courteous and professional attitude during the initial meeting and throughout the course of the inspection. It should be kept in mind that FDA investigators are just doing their job. Therefore, it is important that you project an air of cordiality and cooperation. An adversarial approach should be avoided at all times. You don't want to alienate the investigators and make the inspection uncomfortable for all, especially the firm under scrutiny. Keep in mind that the agency maintains establishment files, and to have a reputation as confrontational will not make life easier for your company.

During the initial meeting, it is highly recommended that a scribe and/or runner be called in to act as recording secretary and expediter for document retrieval and for contacting staff who may be required to participate during the course of the inspection. It is also recommended that you explain your firm's policy with respect to photography, tape recording, and the signing of affidavits.

The primary contact is the firm's inspection facilitator. The contact's rapport with the investigators is a key factor during the course of an inspection. It is important to keep in mind that one of this person's major responsibilities is to speed the inspection process. From the firm's perspective, the time spent during a regulatory inspection is a highly disruptive period.


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