# RR Donnelley Global Turnkey Solutions · 89-08 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For RR Donnelley Global Turnkey Solutions · 89-08 · MEXICO, 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 MEXICO; product is Exa SARS- CoV-2 Rapid Antigen Test; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 04/04/2022; address is Blvd Internacional 881 , San Jeronimo, Cd , Juarez, Chihuahua MEXICO, verified against its source on 2026-09-16.

- **Firm:** RR Donnelley Global Turnkey Solutions _(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:** MEXICO _(verified: appears in the quote below)_
- **Address:** Blvd Internacional 881 , San Jeronimo, Cd , Juarez, Chihuahua MEXICO _(verified: appears in the quote below)_
- **Date published:** 04/04/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** Exa SARS- CoV-2 Rapid Antigen Test _(verified: appears in the quote below)_

## What the source says

> RR Donnelley Global Turnkey Solutions Date Published : 04/04/2022 Blvd Internacional 881 , San Jeronimo, Cd , Juarez, Chihuahua MEXICO 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: Exa SARS- CoV-2 Rapid Antigen Test

## 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/).