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# Multiple GLP Violations at China’s Jiangsu Kerbio
- URL: https://www.fdaweb.com/multiple-glp-violations-at-chinas-jiangsu-kerbio/
- Published: 2025-08-26T12:00:00.000Z
- Updated: 2026-09-14T15:20:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159757

A 1/15-1/24 inspection by the FDA Office of Bioresearch Monitoring Inspectorate Foreign Inspection Cadre at Jiangsu Kerbio Medical Technology Group Co. in Jiangsu Sheng, China, found serious violations of good laboratory practice for nonclinical laboratory studies regulations. A just-released 7/11 Warning Letter says the specific violations were:

- failure of the study director to assure that **(1)** the protocol, including any change, is approved as provided in regulations and is followed; **(2)** all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified; and **(3)** all applicable good laboratory practice regulations are followed;
- 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, including the date and quantity of each batch distributed or returned;
- failure of the quality assurance unit 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;
- 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 assure the quality and integrity of the data generated in the course of a study, and failure of the study director to authorize all deviations in the study from standard operating procedures and ensure that deviations are documented in the raw data;
- failure of the testing facility to ensure that all newly received animals from outside sources were isolated and their health status evaluated according to acceptable veterinary medical practice;
- 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, received appropriate identification;
- failure to provide a separate laboratory space, as needed, for the performance of the routine and specialized procedures required by nonclinical laboratory studies; and
- failure of the quality assistance unit 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.

FDA acknowledges the company’s statement that it was suspending all FDA-related nonclinical testing for a minimum of three years, until 12/31/2027\. The letter gives the company 15 working days to respond with documentation of the additional corrective and preventive actions it has taken to correct the violations and prevent their recurrence.