Globalemed Sa Pty Ltd
⚠️ Moderate Risk
FEI: 3006039599 • Cape Town • SOUTH AFRICA
FEI Number
3006039599
Location
Cape Town
Country
SOUTH AFRICAAddress
Unit 9 Montague Square Montague, Garden, Cape Town, , South Africa
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
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).
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).
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.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2011 | 81MTKKIT, SAMPLE COLLECTION, HIV | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/3/2011 | 91NEDKIT, TEST, MALARIA, | New Orleans District Office (NOL-DO) | |
| 1/3/2011 | 57FB56HEPATITIS B SURFACE ANTIGEN (IN-VITRO DIAGNOSTIC PRODUCTS) | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 8/18/2009 | 83GRTANTISERUM, FLUORESCENT, MYCOBACTERIUM TUBERCULOSIS | 237NO PMA | New Orleans District Office (NOL-DO) |
| 8/18/2009 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 237NO PMA | New Orleans District Office (NOL-DO) |
| 8/18/2009 | 83LIPENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 237NO PMA | New Orleans District Office (NOL-DO) |
| 8/18/2009 | 82MZFTEST, HIV DETECTION | 237NO PMA | New Orleans District Office (NOL-DO) |
| 5/19/2008 | 83LGBGONOCOCCAL ANTIBODY TESTS | 118NOT LISTED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Globalemed Sa Pty Ltd's FDA import refusal history?
Globalemed Sa Pty Ltd (FEI: 3006039599) has 8 FDA import refusal record(s) in our database, spanning from 5/19/2008 to 1/3/2011.
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. Globalemed Sa Pty Ltd's FEI number is 3006039599.
What types of violations has Globalemed Sa Pty Ltd received?
Globalemed Sa Pty Ltd has been cited for 4 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 Globalemed Sa Pty Ltd come from?
All FDA import refusal data for Globalemed Sa Pty Ltd 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.