Reliable Overseas
⚠️ Moderate Risk
FEI: 3011217027 • New Delhi, Delhi • INDIA
FEI Number
3011217027
Location
New Delhi, Delhi
Country
INDIAAddress
2741/1 Street No 13, , New Delhi, Delhi, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/18/2015 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | San Francisco District Office (SAN-DO) | |
| 5/18/2015 | 56YDR99ANTIBIOTIC N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/14/2014 | 21HGH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE | 249FILTHY | San Francisco District Office (SAN-DO) |
| 11/14/2013 | 54IBT02PSYLLIUM (FIBER) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 11/14/2013 | 54IBT02PSYLLIUM (FIBER) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 11/14/2013 | 62FAL99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/14/2013 | 62FAL99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/14/2013 | 60LBJ99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/14/2013 | 62FAY99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/14/2013 | 62FAY99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/14/2013 | 62GBL99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/14/2013 | 60LBL99ANALGESIC, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/18/2013 | 60LBL99ANALGESIC, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Reliable Overseas's FDA import refusal history?
Reliable Overseas (FEI: 3011217027) has 13 FDA import refusal record(s) in our database, spanning from 10/18/2013 to 5/18/2015.
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. Reliable Overseas's FEI number is 3011217027.
What types of violations has Reliable Overseas received?
Reliable Overseas 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 Reliable Overseas come from?
All FDA import refusal data for Reliable Overseas 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.