Royal Exports
⚠️ Moderate Risk
FEI: 3007672035 • Mumbai, Maharashtra • INDIA
FEI Number
3007672035
Location
Mumbai, Maharashtra
Country
INDIAAddress
289/291 Nagdevi Street, K.K. Mansion 2nd Floor, Mumbai, Maharashtra, India
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
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).
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.
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2009 | 65LAJ99PROTECTANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/7/2007 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 5/7/2007 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 3/21/2006 | 61WBR11FUNGIMYCIN (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Southwest Import District Office (SWI-DO) | |
| 8/2/2005 | 61WBR99A-FUNGAL N.E.C. | Baltimore District Office (BLT-DO) | |
| 11/9/2004 | 53DH03POWDERS (DUSTING AND TALCUM, EXCLUDING AFTERSHAVE TALC) (FRAGRANCE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 9/7/2004 | 53DY01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Royal Exports's FDA import refusal history?
Royal Exports (FEI: 3007672035) has 7 FDA import refusal record(s) in our database, spanning from 9/7/2004 to 8/14/2009.
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. Royal Exports's FEI number is 3007672035.
What types of violations has Royal Exports received?
Royal Exports has been cited for 6 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 Royal Exports come from?
All FDA import refusal data for Royal Exports 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.