Globela Pharma Pvt Ltd.
⚠️ Moderate Risk
FEI: 3010703501 • Surat, Gujarat • INDIA
FEI Number
3010703501
Location
Surat, Gujarat
Country
INDIAAddress
3 Plot No 357 - 358, Road No. 4, Surat, Gujarat, 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
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).
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).
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
DIETARYLBL
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(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 11/22/2024 | 66TCC03FEBUXOSTAT (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/28/2021 | 54ACR13VITAMIN C (ASCORBIC ACID) | Division of Southeast Imports (DSEI) | |
| 3/14/2019 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/16/2015 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/3/2015 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | Florida District Office (FLA-DO) | |
| 3/24/2014 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Globela Pharma Pvt Ltd.'s FDA import refusal history?
Globela Pharma Pvt Ltd. (FEI: 3010703501) has 6 FDA import refusal record(s) in our database, spanning from 3/24/2014 to 11/22/2024.
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. Globela Pharma Pvt Ltd.'s FEI number is 3010703501.
What types of violations has Globela Pharma Pvt Ltd. received?
Globela Pharma Pvt Ltd. has been cited for 7 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 Globela Pharma Pvt Ltd. come from?
All FDA import refusal data for Globela Pharma 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.