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Jun 07

No 5: Why It's Best to Cooperate with an Unannounced FDA Inspection

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No. 5: June 7-11, 2010

Why It's Best to Cooperate with an Unannounced FDA Inspection


Dr. McCoy has filed an investigational new drug (IND) application to conduct a clinical study using a marketed drug in a manner that is not approved by the Food and Drug Administration (FDA). Dr. McCoy is the IND sponsor-investigator.

During the clinical trial Dr. McCoy terminates one of his research nurses, Ms. Meyers, because she expresses concern that he is not complying with the applicable IND regulations. She then contacts the local FDA district office and informs the compliance officer of her concerns. The FDA decides that an inspection of Dr. McCoy’s research is warranted.

An FDA investigator shows up unannounced at Dr. McCoy’s research office and issues him a Form FDA 482, Notice of Inspection. Dr. McCoy informs the FDA investigator that patient records are confidential and refuses to allow the investigator access to any documentation regarding the IND study he is conducting.


This is a “for cause” inspection as a result of the information provided by Ms. Meyers. Therefore the FDA shows up unannounced. Dr. McCoy refuses to permit FDA access to the IND records. The FDA investigator issues a Form FDA 483, Notice of Observation, which states “Failure to permit an authorized officer of FDA to have access to, copy, or verify records or reports related to the conduct of the IND study.” Further attempts by FDA to access the records results in Dr. McCoy referring the FDA investigator to his attorney.

Three months later Dr. McCoy receives a warning letter from the FDA.


When the FDA visits a facility and issues a Form FDA 482, allow the investigator to enter and conduct the inspection. Determine the purpose of the visit and cooperate. If the clinical researcher is conducting a clinical trial under an IND there are few documents that the FDA does not have authority to access and copy.

Lesson learned:

Allowing an FDA investigator to conduct a lawful investigation is required by federal regulation. A clinical researcher who has been complying with the obligations of an IND sponsor-investigator should have no concern about the inspection.

There may be observations cited by the investigator, but also opportunity to respond. If the response is satisfactory to the FDA, there will be no sanctions. If the response demonstrates a disregard for the regulations and the protection of human-research subjects, there are consequences. A warning letter is the first of several sanctions at the disposal of the FDA. Warning letters are accessible to all on the FDA Web site (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm).

Pertinent Rule/Regulation:

21 CFR 312.58 and 312.68 state that an IND sponsor or investigator shall, upon request from any properly authorized officer or employee of the FDA at reasonable times, permit such officer or employee to have access to, copy, and verify any records and reports relating to a clinical investigation conducted under an IND. Failure to do so constitutes a refusal to permit inspection of records to which FDA is entitled to access.

Comments by Harvey M. Arbit, PharmD, MBA, president of Arbit Consulting, LLC. He specializes in FDA regulatory affairs related to investigator-initiated IND and IDE research.

Comments (3)
what are the consequences of being issued a "warning letter: from the FDA?
written by Jeff Punch, June 08, 2010
Just curious
written by Dr. Arbit, June 08, 2010
Resonse to Jeff Punch. A warning letter signifies that the one inspected has committed serious violations of the Food, Drug, and Cosmetic Act and the Code of Federal Regulations. Warning letters are public information so your violative actions are available to the public. The suverity of the violations and the response to correct those violations will impact on the sanctions levied by the FDA. The warning letter may be all that happens or the FDA can disqualify an investigator, refuse to accept the data to support a marketing application, prosecute, fine or incarcerate. Warning leters may be just that - a warning. Or they can be career damaging.
written by David Williams, June 08, 2010
These anecdotes and correspondence comprise a form of CME, and the organization should find some way to formalize this so that readers can accumulate points for CPPI accreditation

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