Fidia Farmaceutici S.p.A.
⚠️ Moderate Risk
FEI: 3002806986 • Abano Terme, Padova • ITALY
FEI Number
3002806986
Location
Abano Terme, Padova
Country
ITALYAddress
Via Ponte Della Fabbrica 3/A, , Abano Terme, 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
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/2/2023 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 9/14/2022 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 9/3/2021 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 3/12/2021 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Northern Border Imports (DNBI) | |
| 1/15/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2017 | 64XCA11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/13/2016 | 62FCO38SILVER SULFADIAZINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/31/2013 | 89MOZACID, HYALURONIC, INTRAARTICULAR | New Orleans District Office (NOL-DO) | |
| 6/8/2010 | 80MMSLUBRICANT, VAGINAL, PATIENT | Cincinnati District Office (CIN-DO) | |
| 10/30/2007 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | New Orleans District Office (NOL-DO) | |
| 4/11/2006 | 78MRESOLUTION, SODIUM HYALURONATE | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 2/1/2006 | 89LZXACID, SODIUM HYALURONIC, INTRA-ARTICULAR | Division of Southeast Imports (DSEI) | |
| 12/6/2005 | 63XDL99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/6/2005 | 63XDL99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Fidia Farmaceutici S.p.A.'s FDA import refusal history?
Fidia Farmaceutici S.p.A. (FEI: 3002806986) has 14 FDA import refusal record(s) in our database, spanning from 12/6/2005 to 7/2/2023.
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. Fidia Farmaceutici S.p.A.'s FEI number is 3002806986.
What types of violations has Fidia Farmaceutici S.p.A. received?
Fidia Farmaceutici S.p.A. has been cited for 11 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 Fidia Farmaceutici S.p.A. come from?
All FDA import refusal data for Fidia Farmaceutici S.p.A. 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.