Symbiotec Pharmalab Limited
⚠️ High Risk
FEI: 3009298759 • Pithampur, Madhya Pradesh • INDIA
FEI Number
3009298759
Location
Pithampur, Madhya Pradesh
Country
INDIAAddress
Plot 5,6,7,8, Sez, Phase Ii, Pharma Zone, Dist. Dhar, Pithampur, Madhya Pradesh, 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).
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.
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).
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.
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2023 | 64GDS17ESTERIFIED ESTROGENS (ESTROGENS) | Division of Southeast Imports (DSEI) | |
| 2/24/2023 | 64LIS38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 2/24/2023 | 64LIS38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 5/21/2019 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 186INSANITARY | Division of Southeast Imports (DSEI) |
| 5/30/2017 | 64LCT44METHYLPREDNISOLONE (GLUCOCORTICOID) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 7/11/2014 | 64GDY99ESTROGEN N.E.C. | 27DRUG GMPS | Seattle District Office (SEA-DO) |
| 4/18/2014 | 64GCZ17ESTERIFIED ESTROGENS (ESTROGENS) | Chicago District Office (CHI-DO) | |
| 3/5/2014 | 64GCZ17ESTERIFIED ESTROGENS (ESTROGENS) | Chicago District Office (CHI-DO) | |
| 11/14/2013 | 64GCS17ESTERIFIED ESTROGENS (ESTROGENS) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/14/2013 | 64GCS17ESTERIFIED ESTROGENS (ESTROGENS) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/14/2013 | 64GCS17ESTERIFIED ESTROGENS (ESTROGENS) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Symbiotec Pharmalab Limited's FDA import refusal history?
Symbiotec Pharmalab Limited (FEI: 3009298759) has 11 FDA import refusal record(s) in our database, spanning from 11/14/2013 to 11/3/2023.
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 Limited's FEI number is 3009298759.
What types of violations has Symbiotec Pharmalab Limited received?
Symbiotec Pharmalab Limited 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 Symbiotec Pharmalab Limited come from?
All FDA import refusal data for Symbiotec Pharmalab 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.