Pharmaplast S.A.E.
⚠️ Moderate Risk
FEI: 3003767891 • Alexandria, Al Iskandariyah • EGYPT
FEI Number
3003767891
Location
Alexandria, Al Iskandariyah
Country
EGYPTAddress
Amria Free Zone, 30 Beside Lord International Factory Building, Alexandria, Al Iskandariyah, Egypt
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).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2024 | 64XCY06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 7/18/2024 | 64XCY06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 7/18/2024 | 64XCY06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 7/18/2024 | 64XCY06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 7/18/2024 | 64XCY06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 7/18/2024 | 64XCY06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/21/2015 | 79FRODRESSING, WOUND, DRUG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharmaplast S.A.E.'s FDA import refusal history?
Pharmaplast S.A.E. (FEI: 3003767891) has 7 FDA import refusal record(s) in our database, spanning from 8/21/2015 to 7/18/2024.
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. Pharmaplast S.A.E.'s FEI number is 3003767891.
What types of violations has Pharmaplast S.A.E. received?
Pharmaplast S.A.E. 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 Pharmaplast S.A.E. come from?
All FDA import refusal data for Pharmaplast S.A.E. 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.