Sterling Biotech Limited
⚠️ High Risk
FEI: 3005626665 • Gujarat • INDIA
FEI Number
3005626665
Location
Gujarat
Country
INDIAAddress
Sandesara Estate, Padra Road, Ataladara, Vadodara, Gujarat, , 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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it 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.
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).
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
FILTH
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/26/2013 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | Florida District Office (FLA-DO) | |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
| 10/17/2012 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 78STERILITY | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Sterling Biotech Limited's FDA import refusal history?
Sterling Biotech Limited (FEI: 3005626665) has 18 FDA import refusal record(s) in our database, spanning from 10/17/2012 to 12/26/2013.
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. Sterling Biotech Limited's FEI number is 3005626665.
What types of violations has Sterling Biotech Limited received?
Sterling Biotech Limited has been cited for 4 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 Sterling Biotech Limited come from?
All FDA import refusal data for Sterling Biotech 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.