Syndell Laboratories
⚠️ Moderate Risk
FEI: 1000194876 • Qualicum Beach, Bc • CANADA
FEI Number
1000194876
Location
Qualicum Beach, Bc
Country
CANADAAddress
958 Chatsworth Rd, , Qualicum Beach, Bc, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2005 | 64RKK99HORMONE N.E.C. | 72NEW VET DR | San Francisco District Office (SAN-DO) |
| 8/29/2005 | 68YCY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/10/2005 | 68FDY20HORMONES USED MORE THAN 1 SPECIES | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/10/2004 | 80KZEINJECTOR, FLUID, NON-ELECTRICALLY POWERED | Cincinnati District Office (CIN-DO) | |
| 3/10/2004 | 64RLY99HORMONE N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 5/20/2002 | 68FYY99OTHER ANIMAL, N.E.C. HORMONES | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Syndell Laboratories's FDA import refusal history?
Syndell Laboratories (FEI: 1000194876) has 6 FDA import refusal record(s) in our database, spanning from 5/20/2002 to 9/29/2005.
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. Syndell Laboratories's FEI number is 1000194876.
What types of violations has Syndell Laboratories received?
Syndell Laboratories 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 Syndell Laboratories come from?
All FDA import refusal data for Syndell Laboratories 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.