Abon Biopharm (Hangzhou) Co., Ltd – FDA Warning Letter, Sep 21, 2010

On December 22, 2010, the FDA issued a Warning Letter to Abon Biopharm (Hangzhou) Co. Ltd. following an inspection from September 19-21, 2010. The inspection revealed that the firm's rapid test kits, including fertility, infectious disease, tumor marker, and drug of abuse tests, are adulterated under 21 U.S.C. 351(h) because their manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Specific violations include: 1. **Failure to adequately validate processes (21 CFR 820.75(a)):** The firm failed to adequately validate the temperature control of its 400 m² storage warehouse, where most finished products require storage at 2-30°C. Deficiencies included lack of documentation for material volume, A/C unit settings, thermometer placement, and window curtain status during validation. The firm's response was deemed inadequate as a revised protocol and report were not provided. 2. **Failure to establish and maintain adequate sampling procedures (21 CFR 820.250(b)):** The firm's Final Testing Procedures for Class II devices, such as hCG pregnancy tests, did not comply with its own "Statistical Sampling Quality Control Inspection and Testing of