Hovione FarmaCiencia SA
⚠️ Moderate Risk
FEI: 3002807208 • Loures, Lisbon • PORTUGAL
FEI Number
3002807208
Location
Loures, Lisbon
Country
PORTUGALAddress
Sete Casas, Quinta S. Pedro, Loures, Lisbon, Portugal
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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2018 | 56EYS61MINOCYCLINE HYDROCHLORIDE (TETRACYCLINES) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 4/23/2014 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/23/2014 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/23/2014 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/10/2012 | 56YIS99ANTIBIOTIC N.E.C. | Chicago District Office (CHI-DO) | |
| 10/18/2007 | 56EAS22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/27/2007 | 56EAS22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/7/2007 | 56ECS22DOXYCYCLINE HYCLATE (TETRACYCLINES) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hovione FarmaCiencia SA's FDA import refusal history?
Hovione FarmaCiencia SA (FEI: 3002807208) has 8 FDA import refusal record(s) in our database, spanning from 3/7/2007 to 1/22/2018.
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. Hovione FarmaCiencia SA's FEI number is 3002807208.
What types of violations has Hovione FarmaCiencia SA received?
Hovione FarmaCiencia SA 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 Hovione FarmaCiencia SA come from?
All FDA import refusal data for Hovione FarmaCiencia SA 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.