Puujee Boroo Gold
⚠️ Moderate Risk
FEI: 3010615616 • Tschingeltei, Ulan-bator • MONGOLIA
FEI Number
3010615616
Location
Tschingeltei, Ulan-bator
Country
MONGOLIAAddress
Bodi Tower 11th Floor Sukhbaatar Square, , Tschingeltei, Ulan-bator, Mongolia
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).
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).
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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/13/2014 | 80KZHINTRODUCER, SYRINGE NEEDLE | Los Angeles District Office (LOS-DO) | |
| 11/13/2014 | 61FDA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/13/2014 | 61FDA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/13/2014 | 56KYY99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/13/2014 | 56IDA10ERYTHROMYCIN (MACROLIDES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/13/2014 | 56BDK52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Puujee Boroo Gold's FDA import refusal history?
Puujee Boroo Gold (FEI: 3010615616) has 6 FDA import refusal record(s) in our database, spanning from 11/13/2014 to 11/13/2014.
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. Puujee Boroo Gold's FEI number is 3010615616.
What types of violations has Puujee Boroo Gold received?
Puujee Boroo Gold 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 Puujee Boroo Gold come from?
All FDA import refusal data for Puujee Boroo Gold 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.