# Changzhou SPL Company, Ltd. · 66-40 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Changzhou SPL Company, Ltd. · 66-40 · CHINA, import alert is 66-40; import alert name is "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"; country is CHINA; product code is 55 R - - 75 Crude Heparin (Pharmaceutic Necessity) | 55 R - - 99 Pharmaceutic Necessities, N.E.C. | 57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives) | 61 L - - 08 Heparin Sodium (Anti-Coagulant) | 61 L - - 22 Anti-Coagulant Heparin Sol | 61 L - - 30 Heparin Calcium (Anti-Coagulant) | 80 N - - ZW Heparin Vascular access flush | 81 J - - BR Test, Heparin Neutralization | 81 J - - OX Analyzer, Heparin, Automated | 81 K - - FF Assay, Heparin; date published is 09/10/2009; address is West Rd. , Hutang Township, Wujin City , Changzhou City, Jiangsusheng CHINA, verified against its source on 2026-09-16.

- **Firm:** Changzhou SPL Company, Ltd. _(verified: appears in the quote below)_
- **Import alert:** 66-40
- **Import alert name:** "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** West Rd. , Hutang Township, Wujin City , Changzhou City, Jiangsusheng CHINA _(verified: appears in the quote below)_
- **Date published:** 09/10/2009 _(verified: appears in the quote below)_
- **Product code:** 55 R - - 75 Crude Heparin (Pharmaceutic Necessity) | 55 R - - 99 Pharmaceutic Necessities, N.E.C. | 57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives) | 61 L - - 08 Heparin Sodium (Anti-Coagulant) | 61 L - - 22 Anti-Coagulant Heparin Sol | 61 L - - 30 Heparin Calcium (Anti-Coagulant) | 80 N - - ZW Heparin Vascular access flush | 81 J - - BR Test, Heparin Neutralization | 81 J - - OX Analyzer, Heparin, Automated | 81 K - - FF Assay, Heparin _(verified: each item appears in the quote below)_
- **FDA notes:** All heparin products 3/10/2008 | All heparin products 3/10/2008 | All heparin products 3/10/2008 | All heparin products 3/10/2008 | All heparin products 3/10/2008 | All heparin products 3/10/2008 | All heparin products 3/10/2008 | All heparin products 3/10/2008 | All heparin products 3/10/2008 | All heparin products 3/10/2008 _(verified: each item appears in the quote below)_

## What the source says

> Changzhou SPL Company, Ltd. Date Published : 09/10/2009 West Rd. , Hutang Township, Wujin City , Changzhou City, Jiangsusheng CHINA 55 R - - 75 Crude Heparin (Pharmaceutic Necessity) Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 55 R - - 99 Pharmaceutic Necessities, N.E.C. Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives) Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 61 L - - 08 Heparin Sodium (Anti-Coagulant) Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 61 L - - 22 Anti-Coagulant Heparin Sol Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 61 L - - 30 Heparin Calcium (Anti-Coagulant) Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 80 N - - ZW Heparin Vascular access flush Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 81 J - - BR Test, Heparin Neutralization Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 81 J - - OX Analyzer, Heparin, Automated Date Published: 09/10/2009 Notes: All heparin products 3/10/2008 81 K - - FF Assay, Heparin Date Published: 09/10/2009 Notes: All heparin products 3/10/2008

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_189.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/).