Hikma Farmaceutica, (Portugal) S.A.
⚠️ Moderate Risk
FEI: 3002807173 • Terrugem Snt, Lisboa • PORTUGAL
FEI Number
3002807173
Location
Terrugem Snt, Lisboa
Country
PORTUGALAddress
Estrada Do Rio Da Mo, , Terrugem Snt, Lisboa, 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
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).
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.
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 |
|---|---|---|---|
| 5/4/2016 | 62TIY07PANTOPRAZOLE SODIUM | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 5/14/2014 | 66KCP04DOXERCALCIFEROL (THYROID INHIBITOR) | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 5/14/2014 | 66KCP04DOXERCALCIFEROL (THYROID INHIBITOR) | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 5/14/2014 | 66KCP04DOXERCALCIFEROL (THYROID INHIBITOR) | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 3/26/2014 | 62OIK31ESMOLOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/5/2011 | 61CCP07SODIUM FERRIC GLUCONATE COMPLEX IN SUCRO (ANTI-ANEMIC) | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 5/13/2005 | 56CCZ11CEFAZOLIN SODIUM (CEPHALOSPORINS) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hikma Farmaceutica, (Portugal) S.A.'s FDA import refusal history?
Hikma Farmaceutica, (Portugal) S.A. (FEI: 3002807173) has 7 FDA import refusal record(s) in our database, spanning from 5/13/2005 to 5/4/2016.
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. Hikma Farmaceutica, (Portugal) S.A.'s FEI number is 3002807173.
What types of violations has Hikma Farmaceutica, (Portugal) S.A. received?
Hikma Farmaceutica, (Portugal) S.A. 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 Hikma Farmaceutica, (Portugal) S.A. come from?
All FDA import refusal data for Hikma Farmaceutica, (Portugal) S.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.