Findings
1Laboratory and QC controls
Failure to retain all raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from (b)(4) tests and (b)(4) ) generated as a result of a nonclinical laboratory study. [ 21 CFR § 58.190(a)]. For example: a. Twelve (12) of 48 animals surgically treated with the test or control article were missing original source Laboratory Animal Anesthesia Records, which contain details of the surgical procedure for test or control article…
2Laboratory and QC controls
Failure to include in the final report a description of all circumstances that may have affected the quality or integrity of the data for each nonclinical laboratory study. [21 CFR § 58.185(a)(9)]. You failed to include all data observed for Study (b)(4) in the final Study Report. Data that were not included in the final report include, but are not limited to: Animal Number Source Document Assessment/Comment Assessment Date (b)(4) Daily Clinical Observations Nervous tapping…
3Laboratory and QC controls
The study director failed to assure that the protocol, including any change, is approved as provided by 21 CFR § 58.120 and is followed; that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified; and that unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented. Additionally, all…
4Laboratory and QC controls
Failure of the QAU to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection. [21 CFR § 58.35(b)(3)]. The QAU is responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP regulations. 21 CFR § 58.35(a). a. Your QAU failed to maintain a…
5Laboratory and QC controls
Failure to ensure that each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study has education, training, and experience, or a combination thereof, to enable that individual to perform the assigned functions; that each testing facility maintains a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study; and that for each…
About this record
Extracted automatically from the document US FDA published on 2022-08-09. 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.
