RECHEM INCORPORATED
⚠️ Moderate Risk
FEI: 3014843970 • Kitchener, Ontario • CANADA
FEI Number
3014843970
Location
Kitchener, Ontario
Country
CANADAAddress
22 Frederick St, , Kitchener, Ontario, 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
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.
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 |
|---|---|---|---|
| 6/23/2021 | 60RCY15PHENMETRAZINE HCL (ANOREXIC) | Division of Southeast Imports (DSEI) | |
| 5/12/2020 | 60RCY15PHENMETRAZINE HCL (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2019 | 60RCY15PHENMETRAZINE HCL (ANOREXIC) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 12/16/2019 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 12/2/2019 | 60RCY15PHENMETRAZINE HCL (ANOREXIC) | Division of Southeast Imports (DSEI) | |
| 10/22/2019 | 60RCY15PHENMETRAZINE HCL (ANOREXIC) | Division of Southeast Imports (DSEI) | |
| 1/28/2019 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/4/2018 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is RECHEM INCORPORATED's FDA import refusal history?
RECHEM INCORPORATED (FEI: 3014843970) has 8 FDA import refusal record(s) in our database, spanning from 12/4/2018 to 6/23/2021.
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. RECHEM INCORPORATED's FEI number is 3014843970.
What types of violations has RECHEM INCORPORATED received?
RECHEM INCORPORATED 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 RECHEM INCORPORATED come from?
All FDA import refusal data for RECHEM INCORPORATED 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.