Fleming Laboratories Limited
⚠️ Moderate Risk
FEI: 3007931994 • Medak district, Telangana • INDIA
FEI Number
3007931994
Location
Medak district, Telangana
Country
INDIAAddress
Survey No 270; Nawabpet Village, Shivampet Mandal, Medak district, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2020 | 66MRR83HYDROXYZINE HCL (TRANQUILIZER) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/1/2011 | 65QCS60CYCLOBENZAPRINE HYDROCHLORIDE (RELAXANT) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 2/1/2011 | 61TAS11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 27DRUG GMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Fleming Laboratories Limited's FDA import refusal history?
Fleming Laboratories Limited (FEI: 3007931994) has 3 FDA import refusal record(s) in our database, spanning from 2/1/2011 to 3/19/2020.
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. Fleming Laboratories Limited's FEI number is 3007931994.
What types of violations has Fleming Laboratories Limited received?
Fleming Laboratories Limited has been cited for 1 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 Fleming Laboratories Limited come from?
All FDA import refusal data for Fleming Laboratories Limited 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.