Gian Paolo Ratm
⚠️ Moderate Risk
FEI: 3003722750 • Padova, Padova • ITALY
FEI Number
3003722750
Location
Padova, Padova
Country
ITALYAddress
Via Niccolo' Tommaseo 24, , Padova, Padova, Italy
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/31/2004 | 79MPNTISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 2/3/2003 | 61KCP99ANTI-CHOLINERGIC, N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/12/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Gian Paolo Ratm's FDA import refusal history?
Gian Paolo Ratm (FEI: 3003722750) has 3 FDA import refusal record(s) in our database, spanning from 1/12/2003 to 8/31/2004.
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. Gian Paolo Ratm's FEI number is 3003722750.
What types of violations has Gian Paolo Ratm received?
Gian Paolo Ratm 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 Gian Paolo Ratm come from?
All FDA import refusal data for Gian Paolo Ratm 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.