Nanjing Machinery
⚠️ Moderate Risk
FEI: 1000607425 • Nanjing, Guangdong • CHINA
FEI Number
1000607425
Location
Nanjing, Guangdong
Country
CHINAAddress
255 Shanzhong Rd, , Nanjing, Guangdong, 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).
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).
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.
UNSFDIETSP
The article appears to be a dietary supplement or 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2005 | 54YAS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3100ANDRO | New York District Office (NYK-DO) |
| 7/22/2004 | 54YAS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | New York District Office (NYK-DO) |
| 7/16/2003 | 64RCY99HORMONE N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/30/2003 | 64RCY99HORMONE N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/2/2003 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 5/21/2003 | 60NCR14TESTOSTERONE (ANDROGEN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/21/2003 | 60KCR99ANABOLIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nanjing Machinery's FDA import refusal history?
Nanjing Machinery (FEI: 1000607425) has 7 FDA import refusal record(s) in our database, spanning from 5/21/2003 to 3/28/2005.
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. Nanjing Machinery's FEI number is 1000607425.
What types of violations has Nanjing Machinery received?
Nanjing Machinery has been cited for 5 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 Nanjing Machinery come from?
All FDA import refusal data for Nanjing Machinery 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.