Changzhou Dahua Imp. & Exp. (Group) Corp., Ltd.
⚠️ Moderate Risk
FEI: 3009918183 • Changzhou, Jiangsu • CHINA
FEI Number
3009918183
Location
Changzhou, Jiangsu
Country
CHINAAddress
Hengyuan Building Fl 8-10, NO. 180 Guanhexilu; Zhonglou, Changzhou, Jiangsu, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2010 | 60QAS56BENZOCAINE (ANESTHETIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 4/20/2005 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/28/2005 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3100ANDRO | New York District Office (NYK-DO) |
| 2/28/2005 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3100ANDRO | New York District Office (NYK-DO) |
| 10/8/2004 | 64LCS58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 10/8/2004 | 60DAS99ADRENOCORTICAL STEROID N.E.C. | New York District Office (NYK-DO) | |
| 10/8/2004 | 65JCS31PROGESTERONE (PROGESTIN) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Changzhou Dahua Imp. & Exp. (Group) Corp., Ltd.'s FDA import refusal history?
Changzhou Dahua Imp. & Exp. (Group) Corp., Ltd. (FEI: 3009918183) has 7 FDA import refusal record(s) in our database, spanning from 10/8/2004 to 7/9/2010.
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. Changzhou Dahua Imp. & Exp. (Group) Corp., Ltd.'s FEI number is 3009918183.
What types of violations has Changzhou Dahua Imp. & Exp. (Group) Corp., Ltd. received?
Changzhou Dahua Imp. & Exp. (Group) Corp., 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 Changzhou Dahua Imp. & Exp. (Group) Corp., Ltd. come from?
All FDA import refusal data for Changzhou Dahua Imp. & Exp. (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.