Jiangsu Kerbio Medical Technology Group Co.

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 establish procedures for a system for the handling of the test and control articles to ensure that (1) proper identification is maintained throughout the distribution process and (2) the receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned [21 CFR 58.107(c) and (d)].

Passage 2

Failure of the Quality Assurance Unit (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 and to bring any problems found during the course of an inspection which are likely to affect study integrity to the attention of the study director and management immediately [21 CFR 58.35(b)(3)].

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 testing facility to ensure that all newly received animals from outside sources were isolated and their health status evaluated in accordance with acceptable veterinary medical practice [21 CFR 58.90(b)].

Passage 5

Failure of the testing facility to ensure warm-blooded animals, excluding suckling rodents, used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require the animals to be removed from and returned to their home cages for any reason (e.g., cage cleaning, treatment, etc.) received appropriate identification [21 CFR 58.90(d)].

Passage 6

Failure to provide a separate laboratory space, as needed, for the performance of the routine and specialized procedures required by nonclinical laboratory studies [21 CFR 58.49].

Passage 7

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)].