Findings
1Laboratory and QC controls
Failure of the testing facility to establish standard operating procedures in writing, setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of the studies [21 CFR 58.81(a) and 58.81(b)]. A testing facility must establish and follow written SOPs for nonclinical laboratory studies, to ensure the quality and integrity of the data generated in the studies. Your testing…
2Laboratory and QC controls
Failure of the Quality Assurance unit (QAU) to review the final study report to assure that the reported results accurately reflect the raw data of the nonclinical laboratory study [21 CFR 58.35(b)(6)]. The QAU must review the final study report to ensure that the reported results accurately reflect the raw data of the nonclinical laboratory study. The QAU at your testing facility did not adhere to these requirements. Specifically, for Protocol (b)(4) , the following…
3Equipment and facility
Failure of the testing facility management to assure the availability of equipment as scheduled and that the equipment used in the generation, measurement, or assessment of data shall be of appropriate design and adequate capacity to function according to the study protocol [21 CFR 58.31(e) and 21 CFR 58.61]. Testing facility management must ensure that equipment is available as scheduled. Additionally, equipment used in the generation, measurement, or assessment of data in…
About this record
Extracted automatically from the document US FDA published on 2026-06-02. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
