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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Field Management Directive 120

Subject:
FDA-483, Inspectional Observations
Area:
Operations Management
Date Revised:
December, 29 2009

FIELD MANAGEMENT DIRECTIVE No. 120

 

 

PURPOSE

 

This Field Management Directive (FMD) describes policies for the quality review, distribution of Inspectional Observations (FDA 483), and general guidance for handling unsolicited responses resulting from the issuance of FDA 483s.

 

BACKGROUND

 

Inspectional Observations (FDA 483) are of critical importance to both the Agency and regulated industry. Individual FDA 483s may become public, from a Freedom of Information (FOI) inquiry, soon after an inspection ends. The Food and Drug Administration (FDA) frequently receives unsolicited responses to FDA 483s issued at the conclusion of inspections. These responses may be directed to various persons in the Agency: e.g., the investigator who performed the inspection, the District Director, a Center Director, or the Commissioner. Responses can range from proposed or completed corrections of the FDA 483 items, or a general acknowledgement the firm is evaluating the items listed, to a rebuttal of the items on the FDA 483 with no intent of correction.

 

GUIDANCE

 

All FDA 483s should adhere to the following general principles:

  1. Observations which are listed should be significant and correlate to regulated products or processes being inspected.

 

  1. Observations of questionable significance should not be listed on the FDA 483, but will be discussed with the firm’s management so that they understand how uncorrected problems could become a violation. This discussion will be detailed in the EIR.

 

All FDA 483s should have the following characteristics to be useful and credible documents:

  1. Each observation should be clear and specific.

 

  1. Each should be significant. Length is not necessarily synonymous with significance.

 

  1. Observations should not be repetitious.

 

  1. The observations should be ranked in order of significance.

 

  1. All copies of the FDA 483 should be legible.

 

If an observation made during a prior inspection has not been corrected or is a recurring observation, it is appropriate to note this on the FDA 483.

 

As of 1997, ORA established a FDA 483 annotation policy for medical device inspections. See IOM 5.2.3.4. Regardless of whether an establishment's FDA 483 is annotated, investigators and analysts should make every reasonable effort to discuss all observations with the management of the establishment as they are observed, or on a daily basis, to minimize surprises, errors, and misunderstandings when the FDA 483 is issued. This discussion should include those observations, which may be written on the FDA 483 and those that will only be discussed with management during the closeout meeting. Industry may use this opportunity to ask questions about the observations, request clarification, and inform the inspection team what corrections have been or will be made during the inspection process. Investigators are encouraged to verify the establishment's completed corrective actions as long as the verification does not unreasonably extend the duration of the inspection.

 

There may be instances where same day discussion of observations may not be possible due to the volume of documents collected and document review reveals observations on a different day than the documents were collected or in other circumstances. When these instances occur immediately prior to the conclusion of the inspection, the lack of a daily discussion of observations does not preclude listing of significant observations which were not previously discussed on the FDA 483.

 

During the discussion with management, Investigators should be familiar with the requirements of the timeframes associated with the submission and Agency review of post-inspection responses to inspectional observations, prior to the issuance of Warning Letters, as is referenced in DFI Field Alert  #29  http://inside.fda.gov:9003/PolicyProcedures/GuidanceRegulations/FieldInvestigations/ucm006587.html

 

  1. Distribution

 

The original FDA 483 is to be presented to the most responsible management official available at the firm upon completion of the on-site inspection. Where possible, this is the individual to whom the “Notice of Inspection” was issued. If the person is not available or is outranked by someone else, present the FDA 483 to the individual who meets the definition of owner, operator, or agent in charge.  A copy of the FDA 483 will be sent to the top management official of the firm inspected unless the individual who received the original FDA 483 is the same person.

 

It is important to note that an exact copy of the FDA 483 is to be submitted with the EIR and kept in the official establishment file.

 

District management will avoid prolonged delays in sending the FDA 483 to top management while waiting for a Warning Letter or other correspondence to be approved and issued.

 

  1. Response to FDA 483 Received

 

Unsolicited contact or correspondence concerning a FDA 483 is to be considered an effort by management of a firm to notify FDA of planned or completed corrections, or at least, that they are aware of the FDA 483 and are considering its ramifications.

 

Districts will issue a timely reply to all contact and correspondence from firms regarding FDA 483s. The type and depth of the reply will be based on the content of the contact or correspondence received.

 

The firm may request clarification, criticize FDA 483 items, disagree with the FDA 483, or raise other questions or issues. In these cases, the District will evaluate the firm’s information and send the District’s conclusion to the firm. A copy shall also be sent to the official establishment file.

 

Do not prepare a response which can be construed by the firm as an endorsement of its actions unless such a response is appropriate (which should usually be reserved until after verification). Be cognizant of the effect a reply may have on anticipated or ongoing regulatory actions against the firm.

 

Where no additional issues are to be discussed, simply acknowledging receipt of the firm’s response and indicating that it will become a part of the official file will suffice.

 

The Home District will prepare the response, regardless of the office that received the correspondence from the firm.

 

 

 

                                                                                                                                                             

Distribution:

Regional Food and Drug Directors, District Directors,

 

Laboratory Directors and Headquarter Office Directors

Issued by:

ORA/ORO/Division of Field Investigations (HFC-130)

Authority:

ORA

Publication Date:

December 2009