BAPS Swaminarayan Herbal Care, A Unit of Divine Energy
⚠️ Moderate Risk
FEI: 3004290879 • Sabarkantha, Gujarat • INDIA
FEI Number
3004290879
Location
Sabarkantha, Gujarat
Country
INDIAAddress
Village Majara, Taluk Prantij District, , Sabarkantha, Gujarat, 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
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
TRANSFAT
The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
JUICE %
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(i)(2) of the FD&C Act in that the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/14/2012 | 41YHE99DIETARY CONVENTIONAL FOODS, N.E.C. | New York District Office (NYK-DO) | |
| 8/14/2012 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/14/2012 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is BAPS Swaminarayan Herbal Care, A Unit of Divine Energy's FDA import refusal history?
BAPS Swaminarayan Herbal Care, A Unit of Divine Energy (FEI: 3004290879) has 14 FDA import refusal record(s) in our database, spanning from 8/14/2012 to 12/18/2014.
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. BAPS Swaminarayan Herbal Care, A Unit of Divine Energy's FEI number is 3004290879.
What types of violations has BAPS Swaminarayan Herbal Care, A Unit of Divine Energy received?
BAPS Swaminarayan Herbal Care, A Unit of Divine Energy has been cited for 7 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 BAPS Swaminarayan Herbal Care, A Unit of Divine Energy come from?
All FDA import refusal data for BAPS Swaminarayan Herbal Care, A Unit of Divine Energy 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.