Botanic Healthcare Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3011224521 • Choutuppal, Telangana • INDIA
FEI Number
3011224521
Location
Choutuppal, Telangana
Country
INDIAAddress
28 - 30 Thallasingaram Village, Bhuvanagiri District; Survey No, Choutuppal, Telangana, 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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
INCONSPICU
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2022 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 7/8/2021 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Division of Northern Border Imports (DNBI) |
| 7/8/2021 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Division of Northern Border Imports (DNBI) |
| 2/5/2020 | 54KBT10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 256INCONSPICU | Division of Northern Border Imports (DNBI) |
| 7/19/2019 | 54KBR10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 2120UNSFDIETSP | Division of Northern Border Imports (DNBI) |
| 7/19/2019 | 54KBR10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 2120UNSFDIETSP | Division of Northern Border Imports (DNBI) |
| 7/19/2019 | 54KBR10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 2120UNSFDIETSP | Division of Northern Border Imports (DNBI) |
| 1/17/2019 | 54KYY10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 2120UNSFDIETSP | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Botanic Healthcare Pvt. Ltd.'s FDA import refusal history?
Botanic Healthcare Pvt. Ltd. (FEI: 3011224521) has 8 FDA import refusal record(s) in our database, spanning from 1/17/2019 to 10/21/2022.
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. Botanic Healthcare Pvt. Ltd.'s FEI number is 3011224521.
What types of violations has Botanic Healthcare Pvt. Ltd. received?
Botanic Healthcare Pvt. Ltd. has been cited for 2 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 Botanic Healthcare Pvt. Ltd. come from?
All FDA import refusal data for Botanic Healthcare 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.