Serdia Pharmaceuticals (India)
⚠️ High Risk
FEI: 3005020880 • Mumbai • INDIA
FEI Number
3005020880
Location
Mumbai
Country
INDIAAddress
Serdia House/Off Dr Ss Rao Rd, , 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/15/2026 | 66XDY99HOMEOPATHIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 62OCA03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/27/2019 | 61PDY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2019 | 61DCA99ANTI-ANGINAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/22/2015 | 64BCB48INDAPAMIDE (DIURETIC) | Florida District Office (FLA-DO) | |
| 8/14/2012 | 64BDA48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/7/2011 | 62OCP41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Serdia Pharmaceuticals (India)'s FDA import refusal history?
Serdia Pharmaceuticals (India) (FEI: 3005020880) has 9 FDA import refusal record(s) in our database, spanning from 9/7/2011 to 1/15/2026.
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. Serdia Pharmaceuticals (India)'s FEI number is 3005020880.
What types of violations has Serdia Pharmaceuticals (India) received?
Serdia Pharmaceuticals (India) 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 Serdia Pharmaceuticals (India) come from?
All FDA import refusal data for Serdia Pharmaceuticals (India) 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.