# FCL Health Solutions Ltd · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For FCL Health Solutions Ltd · 89-08 · UNITED KINGDOM, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is UNITED KINGDOM; product is Hyaluronic Acid; product code is 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 02/16/2018; address is Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** FCL Health Solutions Ltd _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 02/16/2018 _(verified: appears in the quote below)_
- **Product code:** 87 M - - OZ Acid, hyaluronic, intraarticular _(verified: appears in the quote below)_
- **Product:** Hyaluronic Acid _(verified: appears in the quote below)_
- **FDA notes:** Class III; _(verified: appears in the quote below)_

## What the source says

> FCL Health Solutions Ltd Date Published : 02/16/2018 Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 02/16/2018 Desc: Hyaluronic Acid Notes: Class III;

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).