| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-07 | VERSION NO.:1.3 | Section 7 – Private Laboratory Guidance | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/27/2008 |
7.5 On-site Assessment Visits
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.
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