KLM LAB PVT LTD
⚠️ High Risk
FEI: 3013708667 • Mumbai • INDIA
FEI Number
3013708667
Location
Mumbai
Country
INDIAAddress
1004 Hubtown Viva Joqoi, , Mumbai, , 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2025 | 62CCY41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 7/25/2025 | 62FAO53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2025 | 64LAO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2025 | 54HFE05OMEGA-3 (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2022 | 66GDY35POLYGLYCOLIC ACID (SURGICAL/PROSTHETIC AID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/19/2021 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is KLM LAB PVT LTD's FDA import refusal history?
KLM LAB PVT LTD (FEI: 3013708667) has 7 FDA import refusal record(s) in our database, spanning from 1/19/2021 to 11/14/2025.
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. KLM LAB PVT LTD's FEI number is 3013708667.
What types of violations has KLM LAB PVT LTD received?
KLM LAB 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 KLM LAB PVT LTD come from?
All FDA import refusal data for KLM LAB 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.