True Form Packaging Inc
⚠️ Moderate Risk
FEI: 3009167995 • Edmonton, Alberta • CANADA
FEI Number
3009167995
Location
Edmonton, Alberta
Country
CANADAAddress
9160 Yellowhead Trail NW, , Edmonton, Alberta, 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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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).
DIETARYING
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
PLANT PART
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2017 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Minneapolis District Office (MIN-DO) | |
| 9/9/2016 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 6/7/2016 | 54ECE99HERBALS & BOTANICAL TEAS, N.E.C. | Seattle District Office (SEA-DO) | |
| 6/7/2016 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 2/5/2013 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is True Form Packaging Inc's FDA import refusal history?
True Form Packaging Inc (FEI: 3009167995) has 5 FDA import refusal record(s) in our database, spanning from 2/5/2013 to 2/21/2017.
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. True Form Packaging Inc's FEI number is 3009167995.
What types of violations has True Form Packaging Inc received?
True Form Packaging Inc has been cited for 9 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 True Form Packaging Inc come from?
All FDA import refusal data for True Form Packaging 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.