Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.
⚠️ High Risk
FEI: 3001599766 • Changzhou, Jiangsu • CHINA
FEI Number
3001599766
Location
Changzhou, Jiangsu
Country
CHINAAddress
Huzhuangtou, No. 302 Sanhuangmiaocun; Zhengluzhen Wujin Districtzhenglu, Tianning, Changzhou, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
ANDRO
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/25/2025 | 65JCR31PROGESTERONE (PROGESTIN) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/18/2024 | 65JCJ31PROGESTERONE (PROGESTIN) | Division of Southeast Imports (DSEI) | |
| 2/22/2021 | 65JAY31PROGESTERONE (PROGESTIN) | Division of West Coast Imports (DWCI) | |
| 1/25/2021 | 64LOY58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 1/14/2020 | 64LIR58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 1/14/2020 | 65JIR31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 2/9/2018 | 65JCR31PROGESTERONE (PROGESTIN) | Division of Southeast Imports (DSEI) | |
| 8/26/2014 | 64LBY58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 8/22/2014 | 60DCT99ADRENOCORTICAL STEROID N.E.C. | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 7/10/2014 | 65JAY31PROGESTERONE (PROGESTIN) | Division of Southeast Imports (DSEI) | |
| 3/27/2014 | 65J31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 10/10/2013 | 65JCR31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 3/28/2013 | 65JAS31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/19/2012 | 65JAS31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 11/3/2011 | 65JIY31PROGESTERONE (PROGESTIN) | Cincinnati District Office (CIN-DO) | |
| 6/22/2011 | 65JCY31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 4/15/2011 | 65JIY99PROGESTIN N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 4/15/2011 | 65JCY31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 2/11/2011 | 65JDZ31PROGESTERONE (PROGESTIN) | Chicago District Office (CHI-DO) | |
| 1/4/2011 | 65JCS31PROGESTERONE (PROGESTIN) | New Orleans District Office (NOL-DO) | |
| 12/14/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 2/1/2010 | 65JDZ31PROGESTERONE (PROGESTIN) | Chicago District Office (CHI-DO) | |
| 9/24/2009 | 64LCS58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/18/2009 | 64LAR38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/18/2009 | 64LAR38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/17/2009 | 60NCS14TESTOSTERONE (ANDROGEN) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 11/25/2008 | 65JAS31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 4/17/2008 | 65JDZ31PROGESTERONE (PROGESTIN) | Seattle District Office (SEA-DO) | |
| 2/25/2008 | 65JCS31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 1/4/2008 | 65JDZ31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 10/18/2007 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 7/12/2007 | 64LIS58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 3/19/2007 | 60NCS14TESTOSTERONE (ANDROGEN) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 3/16/2007 | 64RCS99HORMONE N.E.C. | Minneapolis District Office (MIN-DO) | |
| 1/3/2007 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/13/2006 | 66YCR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/28/2006 | 65JCR31PROGESTERONE (PROGESTIN) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/2/2006 | 60NCS14TESTOSTERONE (ANDROGEN) | 16DIRECTIONS | Atlanta District Office (ATL-DO) |
| 10/24/2006 | 60NCS14TESTOSTERONE (ANDROGEN) | 16DIRECTIONS | Atlanta District Office (ATL-DO) |
| 10/14/2005 | 60NCS14TESTOSTERONE (ANDROGEN) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/13/2005 | 60QCS56BENZOCAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 4/19/2005 | 65JCS31PROGESTERONE (PROGESTIN) | New York District Office (NYK-DO) | |
| 12/29/2004 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/29/2004 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/16/2004 | 64UAR99INHIBITOR N.E.C. | 3100ANDRO | Los Angeles District Office (LOS-DO) |
| 12/15/2004 | 60QCS56BENZOCAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 12/15/2004 | 64LAR38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 9/13/2004 | 65JCS21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | New York District Office (NYK-DO) | |
| 7/19/2004 | 65JCS31PROGESTERONE (PROGESTIN) | Division of Northeast Imports (DNEI) | |
| 5/5/2004 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/4/2003 | 64LRY38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | Detroit District Office (DET-DO) | |
| 11/3/2003 | 65JAY31PROGESTERONE (PROGESTIN) | Seattle District Office (SEA-DO) | |
| 6/6/2003 | 65JCS18HYDROXYPROGESTERONE CAPROATE (PROGESTIN) | Southwest Import District Office (SWI-DO) | |
| 3/11/2003 | 56GAR99ANTIFUNGAL N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/13/2003 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.'s FDA import refusal history?
Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. (FEI: 3001599766) has 56 FDA import refusal record(s) in our database, spanning from 1/13/2003 to 8/25/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.'s FEI number is 3001599766.
What types of violations has Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. received?
Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. come from?
All FDA import refusal data for Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.