Aavishkar Oral Strips Pvt., Ltd.
⚠️ High Risk
FEI: 3012315921 • Hyderabad, Telangana • INDIA
FEI Number
3012315921
Location
Hyderabad, Telangana
Country
INDIAAddress
Ida Phase 2, 109/3 Sector 2; Lane 6, Hyderabad, Telangana, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
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).
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/20/2025 | 54KCY21AMLA (HERBAL & BOTANICALS, NOT TEAS II) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 2/20/2025 | 54FCY91BOSWELLIA (HERBAL & BOTANICALS, NOT TEAS) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 2/20/2025 | 54FCY91BOSWELLIA (HERBAL & BOTANICALS, NOT TEAS) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 2/20/2025 | 54KCY21AMLA (HERBAL & BOTANICALS, NOT TEAS II) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 2/20/2025 | 54CMY20L-TRYPTOPHAN (PROTEIN) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 2/20/2025 | 54AMY16VITAMIN E (TOCOPHEROL) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 2/20/2025 | 54CMY20L-TRYPTOPHAN (PROTEIN) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 2/20/2025 | 54AMY16VITAMIN E (TOCOPHEROL) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 1/25/2023 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 6/24/2021 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 6/24/2021 | 54ABY99VITAMIN, N.E.C. | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 11/27/2017 | 66FBR99SUPPRESSANT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/15/2017 | 66VIG99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 11/15/2017 | 66VIG99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 11/15/2017 | 66VIG99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 6/23/2016 | 65PIY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Aavishkar Oral Strips Pvt., Ltd.'s FDA import refusal history?
Aavishkar Oral Strips Pvt., Ltd. (FEI: 3012315921) has 16 FDA import refusal record(s) in our database, spanning from 6/23/2016 to 2/20/2025.
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. Aavishkar Oral Strips Pvt., Ltd.'s FEI number is 3012315921.
What types of violations has Aavishkar Oral Strips Pvt., Ltd. received?
Aavishkar Oral Strips Pvt., Ltd. 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 Aavishkar Oral Strips Pvt., Ltd. come from?
All FDA import refusal data for Aavishkar Oral Strips Pvt., 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.