HealthPartners Neuroscience Center Research and Innovation

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure of the testing facility management to assure that tests for mixtures of articles with carriers were conducted by appropriate analytical methods to determine the uniformity of the mixture and the concentration of the test or control article in the mixture, as applicable [21 CFR 58.31(d) and 21 CFR 58.113(a)(1)].

Passage 2

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)].

Passage 3

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].

Passage 4

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)].