# Incosmo S.R.L · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For Incosmo S.R.L · 89-08 · ITALY, 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 ITALY; product is Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant; product code is 80 K - - MJ Lubricant, Patient | 80 M - - MS Lubricant, Vaginal, Patient | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible; date published is 03/20/2018; address is Via I Maggio 7 , Biassono, Monza E della Brianza ITALY, verified against its source on 2026-09-16.

- **Firm:** Incosmo S.R.L _(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:** ITALY _(verified: appears in the quote below)_
- **Address:** Via I Maggio 7 , Biassono, Monza E della Brianza ITALY _(verified: appears in the quote below)_
- **Date published:** 03/20/2018 _(verified: appears in the quote below)_
- **Product code:** 80 K - - MJ Lubricant, Patient | 80 M - - MS Lubricant, Vaginal, Patient | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible _(verified: each item appears in the quote below)_
- **Product:** Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant | Long-Lasting Personal Lubricant _(verified: each item appears in the quote below)_

## What the source says

> Incosmo S.R.L Date Published : 03/20/2018 Via I Maggio 7 , Biassono, Monza E della Brianza ITALY 80 K - - MJ Lubricant, Patient Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant 80 M - - MS Lubricant, Vaginal, Patient Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible Date Published: 03/20/2018 Desc: Long-Lasting Personal Lubricant

## 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/).