JHS SVENDGAARD LABORATORIES LTD
⚠️ Moderate Risk
FEI: 3009223273 • Johron, Himachal Pradesh • INDIA
FEI Number
3009223273
Location
Johron, Himachal Pradesh
Country
INDIAAddress
82 85 1 418 67 420 353 1 Kala Amb, Khasra No 179; 89 Trilokpur Road, Johron, Himachal Pradesh, India
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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 |
|---|---|---|---|
| 7/14/2023 | 63RAG06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/27/2019 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/16/2016 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is JHS SVENDGAARD LABORATORIES LTD's FDA import refusal history?
JHS SVENDGAARD LABORATORIES LTD (FEI: 3009223273) has 3 FDA import refusal record(s) in our database, spanning from 3/16/2016 to 7/14/2023.
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. JHS SVENDGAARD LABORATORIES LTD's FEI number is 3009223273.
What types of violations has JHS SVENDGAARD LABORATORIES LTD received?
JHS SVENDGAARD LABORATORIES LTD 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 JHS SVENDGAARD LABORATORIES LTD come from?
All FDA import refusal data for JHS SVENDGAARD LABORATORIES LTD 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.