FDA 483 - Zhejiang Peptites Biotech Co.,Ltd. - September 07, 2023

Zhejiang Peptides Biotech Co., Ltd, an API manufacturer in Shaoxing, Zhejiang, was cited for significant deficiencies during an FDA inspection. Observations included inadequate quality control for highly sensitizing materials, failure to prevent cross-contamination, lack of process validation, and insufficient monitoring of utilities. The firm also lacked a scientifically sound cleaning validation program, particularly concerning shared equipment and high-risk products.