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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Prior Notification to FDA Regulated Industries of Impending Inspections

Subject:
Prior Notification to FDA Regulated Industries of Impending Inspections
Area:
Operations Management
Date Revised:
-

 

 

NOTE: This Field Management Directive is currently being reviewed by the Division of Emergency and Investigational Operations. After revisions are completed, the updated directive will be distributed as a separate issue to all offices on the current distribution list.

PURPOSE

To reaffirm unwritten policy that ORA district management may notify, when conditions warrant, an FDA regulated facility of an impending field inspection or special investigation.

BACKGROUND

It has been, and continues to be, the tradition and policy of the Food and Drug Administration, with very few exceptions, to initiate inspections and special investigations of regulated industries without prior notification to the specific facility or its management of our intent to inspect.

The objective in not providing prior notification is to be able to inspect the establishment under conditions that represent normal day-to-day activities. This in theory, gives a true picture of a firm's level of compliance. It can also be assumed, with due justification, that there are some firms operated by less than honest individuals where prior notification would permit the operator time to achieve some degree of temporary correction. In the case of a clandestine or truly illegal operation, the possibility of the facility not being in operation when the investigator arrives also exists.

In instances where prior notification has been given or is routinely provided; e.g., inspections related to antibiotic certification, foreign facilities inspections, and most recently, inspections of non-clinical bio-research facilities, the practice has been judged to be beneficial to the government by saving manpower and money and has not compromised the inspection. Advantages to FDA will continue to be the only criteria for the decision.

POLICY

ORA recognizes that in unusual situations district management has assumed the responsibility and authority to issue prior notification to an FDA regulated facility of an impending inspection. This has been the exception rather than the rule. This FMD reaffirms previously unstated policy that such notification is justifiable when it is beneficial to the agency and does not compromise the intent of the inspection or our regulatory policy.

GUIDANCE

In certain specific instances, field implementation of compliance programs would be best served by limited prior notification to the regulated industry of our intent to inspect. One program of particular concern, which illustrates the conditions under which prior notification could be used, is the Unlicensed Blood Bank Program. Many interstate blood banks are part of a rural hospital. Unannounced inspections often require the investigator to travel long distances only to find that the hospital administrator and/or pathologist (who may be one and the same person) is either taking care of hospital administrative duties or away from the facility. In either case, he may be the only individual able to provide the proper type of inspection under the program. In such cases, prior notification would prevent unnecessary expenses and travel to these locations by field investigators who, on occasion, learn upon arrival that necessary management personnel are unavailable for the inspection or that the facility has creased operation. As previously mentioned, the practice is utilized in inspection of foreign facilities to avoid similar wasteful expenditures of Government manpower and money.

This authority should not be exercised on a routine basis but only in instances where, in the judgment of the field manager (District Director), the situation warrants prior notification. Pre-notification may be necessary in situations where non-FDA personnel are included in the inspection group. See FMD 37 for foreign visitor planning.

NOTE

Authority to inspect electronic firms related to enforcement of PL 90-602 Radiation Control for Health and Safety Act, 1968, is limited by Center for Devices and Radiological Health interpretation to "good cause" situations. Therefore, CDRH policy that routine surveillance inspections always be made by giving the firm prior notification and obtaining approval. Most of these inspections are performed directly by Center representatives but may be delegated to the field as special assignments.