Isha Agro Developers Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3008366800 • Lonavala - Mawal - Pune, Maharashtra • INDIA
FEI Number
3008366800
Location
Lonavala - Mawal - Pune, Maharashtra
Country
INDIAAddress
Plot No. 36A / 55AB, Lonavala Industrial Co-op Estate Ltd., Lonavala - Mawal - Pune, Maharashtra, 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
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/16/2018 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/13/2016 | 54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/13/2016 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/13/2016 | 54YBA01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 3864NCONTACT | Cincinnati District Office (CIN-DO) |
| 12/13/2016 | 54FBR94ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 3864NCONTACT | Cincinnati District Office (CIN-DO) |
| 12/13/2016 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3864NCONTACT | Cincinnati District Office (CIN-DO) |
| 12/13/2016 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Isha Agro Developers Pvt. Ltd.'s FDA import refusal history?
Isha Agro Developers Pvt. Ltd. (FEI: 3008366800) has 7 FDA import refusal record(s) in our database, spanning from 12/13/2016 to 11/16/2018.
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. Isha Agro Developers Pvt. Ltd.'s FEI number is 3008366800.
What types of violations has Isha Agro Developers Pvt. Ltd. received?
Isha Agro Developers Pvt. 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 Isha Agro Developers Pvt. Ltd. come from?
All FDA import refusal data for Isha Agro Developers 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.