SBL Private Limited
🚨 Critical Risk
FEI: 3013445361 • Haridwar, Uttarakhand • INDIA
FEI Number
3013445361
Location
Haridwar, Uttarakhand
Country
INDIAAddress
Plot No 3 Sector - 12, Iie, Haridwar, Uttarakhand, India
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe violations.
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).
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2025 | 66XCA99HOMEOPATHIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2025 | 66XCA99HOMEOPATHIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/27/2025 | 66XDL07HOMEOPATHIC MULTIPLE INDICATIONS | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66XDL07HOMEOPATHIC MULTIPLE INDICATIONS | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66XDL07HOMEOPATHIC MULTIPLE INDICATIONS | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66XDL07HOMEOPATHIC MULTIPLE INDICATIONS | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66XDL07HOMEOPATHIC MULTIPLE INDICATIONS | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 54YGY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 66WCY99IMMUNOMODULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 66CCY99STOOL SOFTENER N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 66FCY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 60SCY99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 56GCY99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 60LCY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 60LDY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 63HCY08CASTOR OIL (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2023 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2023 | 54FGY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2022 | 61WCA99A-FUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2022 | 61WCA99A-FUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2022 | 54FGY88GYMNEMA SYLVESTRE (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2019 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 65QDY21METAXALONE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 64RDY22SOMATROPIN (RDNA ORIGIN) (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 62IDY24HYDROXYUREA (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 60SDB07PRECIPITATED CALCIUM CARBONATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 61CDB02COBALT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2016 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SBL Private Limited's FDA import refusal history?
SBL Private Limited (FEI: 3013445361) has 63 FDA import refusal record(s) in our database, spanning from 4/22/2016 to 11/25/2025.
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. SBL Private Limited's FEI number is 3013445361.
What types of violations has SBL Private Limited received?
SBL Private Limited 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 SBL Private Limited come from?
All FDA import refusal data for SBL Private Limited 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.