Reference Materials
Subpart A--General Provisions, Sec. 58.15 Inspection of a testing facility
(b) The Food and Drug Administration will not consider a nonclinical laboratory study in support of an application for a research or marketing permit if the testing facility refuses to permit inspection. The determination that a nonclinical laboratory study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to the Food and Drug Administration.
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Glossary
- Warning Letter
- An informal advisory to a firm communicating the agency's position on a matter but does not commit FDA to taking enforcement action. The agency's policy is that Warning Letters should be issued for violations which are of regulatory significance in that failure to adequately and promptly take corrections may be expected to result in enforcement action should the violation(s) continue.