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Volume III - 7.5 On-site Assessment Visits

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-07

VERSION NO.:1.4

Section 7 – Private Laboratory Guidance

EFFECTIVE DATE: 10/01/2003REVISED: 01/30/13

At times, the agency visits the laboratory in order to ascertain that it has the capability or capacity to perform the analyses. Often, these visits are precipitated by an accumulation of elements that may call the laboratory's capabilities into question. Differences from FDA's results on audit samples, repeated borderline or questionable results, or multiple unacceptable packages are typical examples. Alternatively, visits may be made simply in order for the laboratory or district to become familiar with the private laboratories in their vicinity.

The on-site visit provides the opportunity to observe that equipment, reagents, and standards needed to conduct the proposed analyses are present and in good order; to review the adequacy of the laboratory's quality assurance and record-keeping programs; and to observe the techniques and practices of the analysts. Site visits should ideally occur when the analyses at issue can be observed. These information-gathering activities round out the picture of the laboratory's capabilities.

On-site assessment visits are not inspections. They differ in many significant ways. They are voluntary; the laboratory may decline to participate. Neither a Notice of Inspection (Form FDA 482) nor Inspectional Observations (Form FDA 483) is presented. The date of the visit is by appointment. If the visit is being made in connection with a particular package, it should be scheduled in advance with the private laboratory through the importer or broker whose entry is under review. 

A team of inspectional and laboratory personnel may conduct the assessment visits or they may be conducted by experienced FDA laboratory personnel alone. In the latter case, the laboratory personnel should discuss the visit with the home district staff prior to the visit. Ideally, analysts familiar with each of the analytical areas to be observed should participate. 

If the private laboratory is located outside the region of the reviewing component, an ORA laboratory or district closer to the laboratory may be asked to conduct the visit or, if the distance does not pose too great a barrier, analysts from the reviewing laboratory may conduct the on-site assessment. In the latter situation, the home district of the private laboratory should be notified and consulted prior to the visit.

In all cases, inspectors and analysts who conduct on-site assessment visits should be fully briefed with any information about the laboratory prior to the visit. Afterwards, they should prepare a memorandum describing the visit. The memo should be sent to the home district of the private laboratory. The private laboratory or the importer or broker may request a copy under the Freedom of Information Act.