Spec Chem Industry Inc.
⚠️ Moderate Risk
FEI: 3004153089 • Nanjing, Jiangsu • CHINA
FEI Number
3004153089
Location
Nanjing, Jiangsu
Country
CHINAAddress
Shilin Industrial Park, 10 Wanshoulu; Pukou, Nanjing, 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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 6/28/2019 | 63VAS02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 10/1/2014 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 330UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 8/7/2008 | 63VCY99DEPIGMENTOR N.E.C. | New York District Office (NYK-DO) | |
| 10/12/2006 | 88NQFIMMUNOHISTOCHEMISTRY ASSAY, ANTIBODY, EPIDERMAL GROWTH FACTOR RECEPTOR | San Francisco District Office (SAN-DO) | |
| 7/6/2006 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Spec Chem Industry Inc.'s FDA import refusal history?
Spec Chem Industry Inc. (FEI: 3004153089) has 5 FDA import refusal record(s) in our database, spanning from 7/6/2006 to 6/28/2019.
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. Spec Chem Industry Inc.'s FEI number is 3004153089.
What types of violations has Spec Chem Industry Inc. received?
Spec Chem Industry Inc. 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 Spec Chem Industry Inc. come from?
All FDA import refusal data for Spec Chem Industry Inc. 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.