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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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PART II - IMPLEMENTATION

A. Objective

  1. To verify the quality and integrity of data submitted in a research or marketing application.
  2. To inspect (approximately every two years) nonclinical laboratories conducting safety studies that are intended to support applications for research or marketing of regulated products.
  3. To audit safety studies and determine the degree of compliance with GLP regulations.

B. Program Management Instructions

  1. This program provides for the inspection of public, private, and government nonclinical laboratories that perform testing on food and color additives, animal drugs, human drugs and biological products, human medical devices, diagnostic, and electronic products.

    Assignments for the initial GLP inspection of a specific university department or government facility are to be initiated only after the facility has been informed of the agency’s intent to inspect by a letter from the Bioresearch Monitoring Program Coordinator (HFC-230). Notification of subsequent inspections of these laboratory facilities is not necessary.

    Consulting laboratories, contractors, and grantees are covered by the GLPs to the degree that they provide data for a nonclinical laboratory study. The sponsor or person contracting the service must notify them that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part. The consulting laboratory, contractor, or grantee

    Is only required to comply with those parts of the GLPs that are appropriate to the nature of their contributions to a study.

    FDA Centers or ORA headquarters will initiate all nonclinical laboratory inspections.

C. Types of Inspections

  1. Surveillance Inspections
    1. Surveillance inspections are periodic, routine determinations of a laboratory's compliance with GLP regulations. These inspections include a facility inspection and audits of on-going and/or recently completed studies.
  2. Directed Inspections
    1. Directed inspections are assigned to achieve a specific purpose, such as:

      1. Verifying the reliability, integrity, and compliance of critical safety studies being reviewed in support of pending applications.
      2. Investigating issues involving potentially unreliable safety data and/or violative conditions brought to FDA's attention.
      3. Re-inspecting laboratories previously classified OAI (usually within 6 months after the firm responds to a Warning Letter).
      4. Verifying the results from third party audits or sponsor audits submitted to FDA for consideration in determining whether to accept or reject questionable or suspect studies.

D. Inspection Teams (FDA Personnel)

      • Team inspections may be conducted.
      1. Team Leader
        1. A field investigator will serve as team leader and is responsible for the cooperative conduct of the inspection. Responsibilities of the team leader are explained in the Investigations Operations Manual (IOM) 502.4.
      2. Field Analyst/Headquarters Participant
        1. Field analyst or headquarters participant will serve as scientific or technical support to the team leader and shall participate in the inspection by:

          1. Attending pre-inspection conferences when and if scheduled.
          2. Participating in the entire on-site inspection as permitted by agency priorities.
          3. Providing support, as agreed upon with the team leader, in the preparation of specific sections of the inspection report where the field analyst or headquarters participant’s expertise is especially useful.

        Any difficulties involving field analysts or headquarters participants in the inspection should be discussed with District management and, if not resolved, immediately referred to the HFC-130 contact for this program.

E. Joint Inspections with Other Government Agency Personnel

 

Joint inspections with other government agency personnel may be conducted under this program. In all instances, the FDA field investigator will serve as the team leader. Specific instructions for conducting EPA data audits are provided in Compliance Program 7348.808A.

 

F. Confirmation of Schedule

 

All inspections of commercial laboratories are to be conducted without prior notification unless otherwise instructed by the assigning Center. Arrangements to conduct the initial inspection of university and government laboratories should be made soon after the laboratory has received the notification letter from the Bioresearch Monitoring Program Coordinator.

 

G.Field Responsibilities

 

Alert the Bioresearch Monitoring Program Coordinator to facilities that are becoming operational under GLPs. Notify the Center contact identified in the assignment when an inspection has been scheduled (preferably a week or more prior to the start of the inspection) or of any significant delay or postponement of an inspection assignment.