The FDA hit Chinese firm Zhejiang Ludao Technology with a warning letter after an August inspection revealed significant testing issues at its Taizhou, Zhejiang facility.
The firm lacked basic laboratory controls to prevent changes in records for its over-the-counter drug products. It failed to provide analytical test data for four batches of products and created certificates of analysis for them before manufacturing and testing was completed.
Three electronic data files were also found to have been deleted from a computer system used to test finished product, but the firm could not explain why they were deleted, and the agency could not determine how frequently the firm erased test data gathered before batch testing.
The firm also did not test the identity of certain incoming lots of active pharmaceutical ingredients used to manufacture its spray and OTC products. It also did not perform adequate testing to verify the reliability of its API suppliers’ certificate of analyses to ensure conformity with all specifications.
The FDA tested samples of the firm’s OTC spray product and found them to have nearly twice the active ingredient listed on the label. Batches subsequently detained and tested by the agency contained the same excess active ingredient.