Ism Clinic & Lab
⚠️ Moderate Risk
FEI: 3010448325 • Ottawaottawa, ON • CANADA
FEI Number
3010448325
Location
Ottawaottawa, ON
Country
CANADAAddress
302, 80 Aberdeen St*** Ei 10/15/13 ***, , Ottawaottawa, ON, Canada
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
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.
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
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 |
|---|---|---|---|
| 12/9/2013 | 54HCL04FISH OIL (FATS AND LIPID SUBSTANCES) | 2580MFRHACCP | Cincinnati District Office (CIN-DO) |
| 12/9/2013 | 66YBR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/9/2013 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Cincinnati District Office (CIN-DO) | |
| 11/21/2013 | 80LDQDEVICE, GENERAL MEDICAL | Cincinnati District Office (CIN-DO) | |
| 11/21/2013 | 66YBR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ism Clinic & Lab's FDA import refusal history?
Ism Clinic & Lab (FEI: 3010448325) has 5 FDA import refusal record(s) in our database, spanning from 11/21/2013 to 12/9/2013.
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. Ism Clinic & Lab's FEI number is 3010448325.
What types of violations has Ism Clinic & Lab received?
Ism Clinic & Lab 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 Ism Clinic & Lab come from?
All FDA import refusal data for Ism Clinic & Lab 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.