Caregen Co., Ltd.
This firm is named on 2 FDA import alerts in Korea (the Republic of). Shipments from a listed firm may be detained at the port without physical examination. The oldest listing dates to 5 November 2015, the newest to 15 April 2022.
- 2import alerts now
- 10years since the first listing
- 0listings come off
- 30 Augustcopy checked, 2026
Every alert naming this firm
Source: FDA import alerts, mirrored 30 August 2026 · newest listing first
| Alert | Subject | Country | Listed since |
|---|---|---|---|
| 89-08 | Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)78M--RE · 79L--MH | Korea (the Republic of) | 15 April 20224 yr |
| 66-41 | Unapproved New Drugs Promoted In The U.S.53E--07 · 53E--99 · 53L--06 · 53L--07 · 53L--10 · 53L--99 | Korea (the Republic of) | 5 November 201510 yr |
Product classes covered
A listing does not cover everything the factory makes — it covers the FDA product codes named on the alert. These are the codes attached to this firm, with the class FDA prints for each.
| Code | Product class |
|---|---|
| 53E--07 | Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring) |
| 53E--99 | Other Hair Preparations, Non-coloring), N.E.C. |
| 53L--06 | Moisturizing (Skin Care Preparations) |
| 53L--07 | Night (Skin Care Preparations) |
| 53L--10 | Wrinkle Smoothing (Skin Care Preparations) |
| 53L--99 | Other Skin Care Preparations, N.E.C. |
| 78M--RE | Solution, Sodium Hyaluronate |
| 79L--MH | Implant, Dermal, Collagen for Aesthetic Use |
Why this matters under FSVP
If you import this firm's food into the United States, the FSVP rule makes you re-evaluate the supplier when new information comes to light about its performance. An import alert listing is exactly that kind of information. What FSVP requires and where this fits.
This page exists because the firm was on more than one alert when we first saw it, on 30 August 2026. It stays even after the listings come off, because FDA does not publish removals. What moved lately · check another supplier.