Cranberry (M) Sdn Bhd
⚠️ High Risk
FEI: 3002806750 • Ipoh, Perak • MALAYSIA
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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.
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 |
|---|---|---|---|
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 9/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 6/28/2023 | 80FMCGLOVE, PATIENT EXAMINATION | Division of West Coast Imports (DWCI) | |
| 10/26/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 11/19/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 2780DEVICEGMPS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Cranberry (M) Sdn Bhd's FDA import refusal history?
Cranberry (M) Sdn Bhd (FEI: 3002806750) has 15 FDA import refusal record(s) in our database, spanning from 11/19/2012 to 9/28/2023.
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. Cranberry (M) Sdn Bhd's FEI number is 3002806750.
What types of violations has Cranberry (M) Sdn Bhd received?
Cranberry (M) Sdn Bhd 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 Cranberry (M) Sdn Bhd come from?
All FDA import refusal data for Cranberry (M) Sdn Bhd 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.