INSPIRATION MFG. & TRADING CO.
⚠️ Moderate Risk
FEI: 3007113238 • Dongguan, Guangdong • CHINA
FEI Number
3007113238
Location
Dongguan, Guangdong
Country
CHINAAddress
Da Lin, # 23 Guan Chang Rd; Shan Town, Dongguan, 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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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 |
|---|---|---|---|
| 8/10/2012 | 76JESFLOSS, DENTAL | Southwest Import District Office (SWI-DO) | |
| 3/17/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 3/17/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 3/17/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 3/17/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 3/17/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 1/24/2011 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 11/19/2008 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 6/21/2002 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is INSPIRATION MFG. & TRADING CO.'s FDA import refusal history?
INSPIRATION MFG. & TRADING CO. (FEI: 3007113238) has 9 FDA import refusal record(s) in our database, spanning from 6/21/2002 to 8/10/2012.
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. INSPIRATION MFG. & TRADING CO.'s FEI number is 3007113238.
What types of violations has INSPIRATION MFG. & TRADING CO. received?
INSPIRATION MFG. & TRADING CO. 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 INSPIRATION MFG. & TRADING CO. come from?
All FDA import refusal data for INSPIRATION MFG. & TRADING CO. 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.