Attix Pharmaceuticals Inc

⚠️ High Risk

FEI: 3011918846 • Toronto, Ontario • CANADA

FEI

FEI Number

3011918846

📍

Location

Toronto, Ontario

🇨🇦

Country

CANADA

🏢

Address

481 University Ave Unit 502, , Toronto, Ontario, Canada

High Risk

FDA Import Risk Assessment

52.3

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

2/21/2018

Latest Refusal

2/21/2018

Earliest Refusal

Score Breakdown

Violation Severity

62.2×40%

Refusal Volume

58.1×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

1628×

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.

1189×

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).

32809×

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.

Refusal History

Date	Product	Violations	Division
2/21/2018	66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	56FCS99PEPTIDE N.E.C.	3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	56FCS99PEPTIDE N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	64RCY17ANASTROZOLE (HORMONE)	118NOT LISTED 16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	56FYT99PEPTIDE N.E.C.	118NOT LISTED 16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	56FCS99PEPTIDE N.E.C.	118NOT LISTED 16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	65PAR02SILDENAFIL CITRATE (REGULATOR)	118NOT LISTED 16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	61XOR29PYRILAMINE MALEATE (ANTI-HISTAMINIC)	118NOT LISTED 16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	118NOT LISTED	Division of Northeast Imports (DNEI)
2/21/2018	65PCT02SILDENAFIL CITRATE (REGULATOR)	118NOT LISTED	Division of Northeast Imports (DNEI)
2/21/2018	64RLT99HORMONE N.E.C.	118NOT LISTED	Division of Northeast Imports (DNEI)
2/21/2018	66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS 3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	56FYT99PEPTIDE N.E.C.	16DIRECTIONS 3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	56FCS99PEPTIDE N.E.C.	16DIRECTIONS 3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	56FYT99PEPTIDE N.E.C.	16DIRECTIONS 3280FRNMFGREG	Division of Northeast Imports (DNEI)
2/21/2018	60SCT21CISAPRIDE (ANTACID)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	64GCT19ETHINYL ESTRADIOL (ESTROGEN)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	64UCT08DUTASTERIDE	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	64UCT08DUTASTERIDE	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	64UCT08DUTASTERIDE	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	62ICT13CHLORAMBUCIL (ANTI-NEOPLASTIC)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	62VCT25FAMCICLOVIR (ANTI-VIRAL)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	62VCT25FAMCICLOVIR (ANTI-VIRAL)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	66YCT99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	61HAR05ZINC PYRITHIONE (ANTI-BACTERIAL)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	54ADR05VITAMIN B12 (CYANOCOBALAMIN)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	61LAR38CLOPIDOGREL BISULFATE (ANTI-COAGULANT)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	60ZOR99ANTIPARASITIC, N.E.C.	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	60ZOR99ANTIPARASITIC, N.E.C.	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	56OYT05ENROFLOXACIN (FLUOROQUINOLONE)	16DIRECTIONS	Division of Northeast Imports (DNEI)
2/21/2018	56OYT05ENROFLOXACIN (FLUOROQUINOLONE)	16DIRECTIONS	Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Attix Pharmaceuticals Inc's FDA import refusal history?

Attix Pharmaceuticals Inc (FEI: 3011918846) has 36 FDA import refusal record(s) in our database, spanning from 2/21/2018 to 2/21/2018.

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. Attix Pharmaceuticals Inc's FEI number is 3011918846.

What types of violations has Attix Pharmaceuticals Inc received?

Attix Pharmaceuticals Inc has been cited for 3 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 Attix Pharmaceuticals Inc come from?

All FDA import refusal data for Attix Pharmaceuticals Inc 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.