PARKSLEY GLOBAL PRIVATE LIMITED
⚠️ High Risk
FEI: 3032967400 • Maharashtra • INDIA
FEI Number
3032967400
Location
Maharashtra
Country
INDIAAddress
Shop No. 1 A 2,Ground Floor, House No. 2146, , Maharashtra, , 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
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 |
|---|---|---|---|
| 11/24/2025 | 61PAN55METFORMIN HCL (ANTI-DIABETIC) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 56CAO72CEFUROXIME SODIUM (CEPHALOSPORINS) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 60LAB14CARBAMAZEPINE (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 64LAO19DEXAMETHASONE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 60SAA99ANTACID, N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 61FAB54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 61TAA26ONDANSETRON (ANTI-EMETIC/NAUSEANT) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 62GAO90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 61MAK24PHENYTOIN SODIUM (ANTI-CONVULSANT) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 61XAK08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 11/24/2025 | 54ADP18VITAMIN K (PHYTONADIONE) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is PARKSLEY GLOBAL PRIVATE LIMITED's FDA import refusal history?
PARKSLEY GLOBAL PRIVATE LIMITED (FEI: 3032967400) has 11 FDA import refusal record(s) in our database, spanning from 11/24/2025 to 11/24/2025.
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. PARKSLEY GLOBAL PRIVATE LIMITED's FEI number is 3032967400.
What types of violations has PARKSLEY GLOBAL PRIVATE LIMITED received?
PARKSLEY GLOBAL PRIVATE LIMITED 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 PARKSLEY GLOBAL PRIVATE LIMITED come from?
All FDA import refusal data for PARKSLEY GLOBAL PRIVATE 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.