F2 Chemical, Ltd.November 3, 2008

FDA 483 - F2 Chemical, Ltd. - November 03, 2008

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Record Details

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.

Company: F2 Chemical, Ltd.
Inspection Date: November 3, 2008
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Jose R. Hernandez

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ID · 2e572e68-0283-4ed6-840b-1f24e86ee86f