Symbiotec Pharmalab Private Limited
⚠️ Moderate Risk
FEI: 3005122933 • Mhow, Madhya Pradesh • INDIA
FEI Number
3005122933
Location
Mhow, Madhya Pradesh
Country
INDIAAddress
385/2 Pithampur Rau Main Road, , Mhow, Madhya Pradesh, 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
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 |
|---|---|---|---|
| 4/4/2013 | 64LCT67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/11/2012 | 64GDS17ESTERIFIED ESTROGENS (ESTROGENS) | New York District Office (NYK-DO) | |
| 3/17/2009 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Symbiotec Pharmalab Private Limited's FDA import refusal history?
Symbiotec Pharmalab Private Limited (FEI: 3005122933) has 3 FDA import refusal record(s) in our database, spanning from 3/17/2009 to 4/4/2013.
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. Symbiotec Pharmalab Private Limited's FEI number is 3005122933.
What types of violations has Symbiotec Pharmalab Private Limited received?
Symbiotec Pharmalab Private Limited 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 Symbiotec Pharmalab Private Limited come from?
All FDA import refusal data for Symbiotec Pharmalab 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.