If the results of an inspection reveal that significant deviations from the GLPs exist, the
laboratory will be sent a regulatory letter that lists the major deviations and that requests a
response within 10 days. The response should describe those actions that the laboratory has
taken or plans to take to effect correction. The response should also encompass items that
were listed on the FDA-483 and those that were discussed during the exit discussion with
laboratory management. A specific timetable should be given for accomplishing the
planned actions. The reasonableness of the timetable will be determined by FDA
compliance staff, based on the needs of the particular situation.
For less significant deviations, the laboratory will be sent a Notice of Adverse Findings
letter that also lists the deviations but that requests a response within 30 days. Again, the
reasonableness of the response will be determined by FDA staff.
