Assia Chemical Industries Ltd - Teva Tech Site
⚠️ Moderate Risk
FEI: 3002913672 • Be'Er Sheva • ISRAEL
FEI Number
3002913672
Location
Be'Er Sheva
Country
ISRAELAddress
Neot Hovav Eco-Ind. Park, Emek Sara, Be'Er Sheva, , Israel
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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2016 | 66NCS04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 8/3/2015 | 66SCS51TADALAFIL | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 7/3/2013 | 62TCS07PANTOPRAZOLE SODIUM | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 7/3/2013 | 62TCS07PANTOPRAZOLE SODIUM | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 7/3/2013 | 62TCS07PANTOPRAZOLE SODIUM | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 1/12/2012 | 61NCS24DOXEPIN HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2011 | 66QCS03PROBENECID (URICOSURIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 5/12/2010 | 66SCS27NIFEDIPINE (VASODILATOR) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 8/3/2009 | 66SIS51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/10/2006 | 61LCS38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 6/9/2005 | 61JCS10FLUVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/19/2005 | 66MCS86LORAZEPAM (TRANQUILIZER) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/24/2004 | 64BCZ24FUROSEMIDE (DIURETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/21/2004 | 62ICS86LEUPROLIDE ACETATE (ANTI-NEOPLASTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Assia Chemical Industries Ltd - Teva Tech Site's FDA import refusal history?
Assia Chemical Industries Ltd - Teva Tech Site (FEI: 3002913672) has 14 FDA import refusal record(s) in our database, spanning from 9/21/2004 to 8/2/2016.
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. Assia Chemical Industries Ltd - Teva Tech Site's FEI number is 3002913672.
What types of violations has Assia Chemical Industries Ltd - Teva Tech Site received?
Assia Chemical Industries Ltd - Teva Tech Site has been cited for 2 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 Assia Chemical Industries Ltd - Teva Tech Site come from?
All FDA import refusal data for Assia Chemical Industries Ltd - Teva Tech Site 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.