Paul Instruments (India)
⚠️ Moderate Risk
FEI: 6750 • Calcutta • 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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2011 | 86HMRMARKER, OCULAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 86HNFSCISSORS, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 86HNRFORCEPS, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 86HNXDEPRESSOR, ORBITAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 86HNASPUD, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 86HNCSPECULA, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 86HNCSPECULA, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/4/2011 | 86HNRFORCEPS, OPHTHALMIC | 479DV QUALITY | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Paul Instruments (India)'s FDA import refusal history?
Paul Instruments (India) (FEI: 6750) has 9 FDA import refusal record(s) in our database, spanning from 2/4/2011 to 8/5/2011.
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. Paul Instruments (India)'s FEI number is 6750.
What types of violations has Paul Instruments (India) received?
Paul Instruments (India) 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 Paul Instruments (India) come from?
All FDA import refusal data for Paul Instruments (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.