FDA Cites Chinese Contract Research Laboratory for GLP Deficiencies

FDA investigators cited JOINN Laboratories (Suzhou) Co., a Chinese nonclinical testing laboratory, for deficiencies involving specimen tracking, laboratory procedures and animal housing facilities during a 5/11-15 inspection.

The agency issued a two-observation Form 483 to the laboratory, located in Taicang, Jiangsu Province, identifying problems with compliance with good laboratory practice (GLP) requirements for nonclinical studies.

The first observation concerned failures to ensure personnel properly performed assigned functions. Investigators found discrepancies in archived specimen records, including a database entry listing 63 wet tissue bags when only 62 were physically verified. The laboratory also failed to update its document management system to reflect the temporary storage location of 34 trays of tissue blocks.

Additional deficiencies included incorrectly labeled tissue slides, a laboratory solution lacking required expiration and storage information, and temperature and humidity records that did not incorporate calibration corrections.

The second observation concerned the suitability of laboratory facilities for conducting nonclinical studies.

Investigators observed pooling liquid and discolored flooring in an animal holding room, bubbling and cracking in corridor flooring, and a defective door-locking mechanism that allowed nonhuman primates to push open a door while undergoing observation.