CCIC Huatongwei International Inspection Co., 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 properly identify specimens used in nonclinical laboratory studies by test system, study, nature, and date of collection [21 CFR 58.130(c)].

Passage 2

Failure to properly label specimens in a manner that precludes error in the recording and storage of data can attribute to evaluating specimens for the wrong animal, wrong implant site, and wrong study. Therefore, the reliability and quality of data of these studies are in question. 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 to ensure that warm-blooded animals, excluding suckling rodents, receive appropriate identification [21 CFR Part 58.90(d)].

Passage 4

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

Passage 5

Failure of the Quality Assurance Unit (QAU) to maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director [21 CFR 58.35(b)(1)].

Passage 6

Failure to prepare final reports that were signed and dated by each of the individual scientists or other professionals involved in the studies [21 CFR 58.185(a)(12)].

Passage 7

Failure to provide for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens and interim and final reports [21 CFR 58.190(b)].