FDA 483 - F2 Chemical, Ltd. - November 03, 2026

An FDA inspection of F2 Chemicals LTD in Preston, U.K., an API producer, revealed two significant observations. The firm's GC analytical method for assay and purity of a product did not consistently use a characterized reference standard, and the external firm providing spiked impurities was never audited. Additionally, F2 Chemicals lacked information on the cleaning agents used by a company servicing reused cylinders.