FDA 483 - Bright Future Pharmaceutical (Hainan) Co., Ltd. - July 11, 2022

An FDA inspection of Bright Future Pharmaceutical (Hainan) Co., Ltd. in Haikou identified significant deficiencies in laboratory controls. The firm failed to establish scientifically sound sampling plans and test procedures for both process and cleaning validations. These lapses raise concerns about the assurance of drug product quality, purity, and the prevention of cross-contamination.