Viva Pharmaceutical Inc
⚠️ Moderate Risk
FEI: 3002704547 • Richmond, British Columbia • CANADA
FEI Number
3002704547
Location
Richmond, British Columbia
Country
CANADAAddress
13880 Viking Pl, , Richmond, British Columbia, 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
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).
DIETARYLBL
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)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
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.
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2018 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/5/2017 | 63RDL99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/27/2017 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/12/2012 | 54HBH04FISH OIL (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/12/2012 | 54HBH04FISH OIL (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/26/2006 | 54GBL99ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C. | Seattle District Office (SEA-DO) | |
| 8/25/2004 | 54FYR12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 2920PESTICIDES | Seattle District Office (SEA-DO) |
| 1/31/2003 | 54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) | |
| 1/31/2003 | 53UD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 1/31/2003 | 54YBA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Viva Pharmaceutical Inc's FDA import refusal history?
Viva Pharmaceutical Inc (FEI: 3002704547) has 10 FDA import refusal record(s) in our database, spanning from 1/31/2003 to 12/12/2018.
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. Viva Pharmaceutical Inc's FEI number is 3002704547.
What types of violations has Viva Pharmaceutical Inc received?
Viva Pharmaceutical Inc has been cited for 10 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 Viva Pharmaceutical Inc come from?
All FDA import refusal data for Viva Pharmaceutical 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.