# SMB Corporation of India · 66-41 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For SMB Corporation of India · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product code is 65 J - - 36 Intrauterine Copper (Progestin) | 85 H - - DT Device, Intrauterine, Contraceptive and Introducer; date published is 09/30/2009; address is 13 34 35 Prem Industrial Estate , Gupha Road , Mumbai, Maharashtra INDIA, verified against its source on 2026-09-16.

- **Firm:** SMB Corporation of India _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** 13 34 35 Prem Industrial Estate , Gupha Road , Mumbai, Maharashtra INDIA _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 65 J - - 36 Intrauterine Copper (Progestin) | 85 H - - DT Device, Intrauterine, Contraceptive and Introducer _(verified: each item appears in the quote below)_
- **FDA notes:** 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502) | 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502) _(verified: each item appears in the quote below)_

## What the source says

> SMB Corporation of India Date Published : 09/30/2009 13 34 35 Prem Industrial Estate , Gupha Road , Mumbai, Maharashtra INDIA 65 J - - 36 Intrauterine Copper (Progestin) Date Published: 09/30/2009 Notes: 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502) 85 H - - DT Device, Intrauterine, Contraceptive and Introducer Date Published: 09/30/2009 Notes: 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.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/).