Reference Source

Changzhou SPL Company, Ltd. · 66-40 · CHINA

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
Import alert
66-40
Import alert name
"Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
Country
CHINA verified
Address
West Rd. , Hutang Township, Wujin City , Changzhou City, Jiangsusheng CHINA verified
Date published
09/10/2009 verified
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 each item verified
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 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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