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

Source: https://www.keypedia.com/records/483/f2-chemical-ltd/2e572e68-0283-4ed6-840b-1f24e86ee86f

> FDA 483 for F2 Chemical, Ltd. on November 03, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: F2 Chemical, Ltd.
- Inspection Date: 2026-11-03
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Jose R. Hernandez](https://www.keypedia.com/people/jose-r-hernandez/7a28c3ee-b023-44cc-b179-b89798e2f72f)

Company: https://www.keypedia.com/companies/f2-chemical-ltd/753ad982-a3c4-46fe-b9f8-4f300b3d6ab7

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd