CIBA VISION Johor Sdn. Bhd.
⚠️ High Risk
FEI: 3006466212 • Gelang Patah • MALAYSIA
FEI Number
3006466212
Location
Gelang Patah
Country
MALAYSIAAddress
No. 1 Jalan Dpb/5, , Gelang Patah, , 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
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.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/25/2019 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Division of Southeast Imports (DSEI) | |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 8/8/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 5/17/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 10/27/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) | |
| 10/22/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) | |
| 10/22/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) | |
| 10/22/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) | |
| 10/16/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 9/3/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 8/27/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/12/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 7/26/2013 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 12/3/2012 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is CIBA VISION Johor Sdn. Bhd.'s FDA import refusal history?
CIBA VISION Johor Sdn. Bhd. (FEI: 3006466212) has 74 FDA import refusal record(s) in our database, spanning from 12/3/2012 to 9/25/2019.
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. CIBA VISION Johor Sdn. Bhd.'s FEI number is 3006466212.
What types of violations has CIBA VISION Johor Sdn. Bhd. received?
CIBA VISION Johor Sdn. Bhd. 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 CIBA VISION Johor Sdn. Bhd. come from?
All FDA import refusal data for CIBA VISION Johor 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.