SPECTRUM LIFE SCIENCES PVT LTD.
⚠️ High Risk
FEI: 3021573146 • Hyderabad, Telangana • INDIA
FEI Number
3021573146
Location
Hyderabad, Telangana
Country
INDIAAddress
Plot No 100, Aleap Industrial Estate; Gajularamaram Quthbullapur, 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
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/13/2025 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 249FILTHY | Division of Southeast Imports (DSEI) |
| 6/13/2025 | 33JXT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | 249FILTHY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SPECTRUM LIFE SCIENCES PVT LTD.'s FDA import refusal history?
SPECTRUM LIFE SCIENCES PVT LTD. (FEI: 3021573146) has 3 FDA import refusal record(s) in our database, spanning from 6/13/2025 to 12/18/2025.
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. SPECTRUM LIFE SCIENCES PVT LTD.'s FEI number is 3021573146.
What types of violations has SPECTRUM LIFE SCIENCES PVT LTD. received?
SPECTRUM LIFE SCIENCES PVT LTD. 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 SPECTRUM LIFE SCIENCES PVT LTD. come from?
All FDA import refusal data for SPECTRUM LIFE SCIENCES 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.