CSPC Ouyi Pharmaceutical Co., Ltd.
⚠️ High Risk
FEI: 2000021110 • Shijiazhuang, Hebei • CHINA
FEI Number
2000021110
Location
Shijiazhuang, Hebei
Country
CHINAAddress
Shijiazhuang Economic & Technological, No. 88 Yangzi Road; Dev. Zone, Shijiazhuang, Hebei, 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
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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/14/2025 | 56IDC76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2025 | 64LDY19DEXAMETHASONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 4/16/2024 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2021 | 64LDY19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2021 | 60LDY21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2020 | 62ICY76ESTRAMUSTINE PHOSPHATE SODIUM (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2015 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | Florida District Office (FLA-DO) | |
| 7/24/2015 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Florida District Office (FLA-DO) | |
| 7/24/2015 | 56YYK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/24/2015 | 54ADL13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/24/2015 | 54ADB05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/12/2012 | 62LBA34PYRIMETHAMINE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/2/2010 | 56KCO12CHLORAMPHENICOL SODIUM SUCCINATE | New York District Office (NYK-DO) | |
| 12/13/2006 | 64BAZ45THEOBROMINE (DIURETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/4/2005 | 54ADN11HYDROXOCOBALAMIN (VITAMIN) | New Orleans District Office (NOL-DO) | |
| 9/29/2004 | 62GCZ42INDOMETHACIN (ANTI-INFLAMMATORY) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is CSPC Ouyi Pharmaceutical Co., Ltd.'s FDA import refusal history?
CSPC Ouyi Pharmaceutical Co., Ltd. (FEI: 2000021110) has 16 FDA import refusal record(s) in our database, spanning from 9/29/2004 to 5/14/2025.
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. CSPC Ouyi Pharmaceutical Co., Ltd.'s FEI number is 2000021110.
What types of violations has CSPC Ouyi Pharmaceutical Co., Ltd. received?
CSPC Ouyi Pharmaceutical Co., Ltd. has been cited for 4 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 CSPC Ouyi Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for CSPC Ouyi Pharmaceutical Co., 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.