Mid-Link Testing Company, Ltd

Selected passages from the FDA letter

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

Passage 1

Failure to conduct nonclinical laboratory studies in accordance with the protocols [21 CFR 58.130(a)].

Passage 2

Failure to follow the protocol impacts the reliability and quality of data contained within the final study report. This in turn adversely impacts a manufacturer’s and FDA’s ability to assess the overall safety and risk of the subject device prior to use in humans as a legally marketed device or for purposes of beginning clinical trials.

Passage 3

Failure of a testing facility to have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to ensure the quality and integrity of the data generated in the course of a study. The study director failed to authorize all deviations in the study from standard operating procedures and ensure the deviations were documented in the raw data [21 CFR 58.81(a)].

Passage 4

Failure of the Quality Assurance Unit (QAU) to fulfill responsibilities [21 CFR 58.35(a),58.35(b)(1), 58.35(b)(5), and 58.35(b)(6)].

Passage 5

Failure to ensure that warm-blooded animals shall receive appropriate identification where all information needed to specifically identify each animal within an animal-housing unit appears on the outside of that unit [21 CFR Part 58.90(d)].

Passage 6

Failure to properly identify each animal within an animal-housing unit raises concerns about the potential for animals to be incorrectly assigned to studies or study groups. The accuracy of study results cannot be verified since the ability to identify specific animals is foundational to being able to draw scientifically valid conclusions from the studies.