Bantry Bay Pharmac
⚠️ Moderate Risk
FEI: 3004128564 • Cape Town • SOUTH AFRICA
FEI Number
3004128564
Location
Cape Town
Country
SOUTH AFRICAAddress
29 Victoria Road, , Cape Town, , South Africa
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
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
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
Frequently Asked Questions
What is Bantry Bay Pharmac's FDA import refusal history?
Bantry Bay Pharmac (FEI: 3004128564) has 2 FDA import refusal record(s) in our database, spanning from 9/22/2003 to 1/9/2008.
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. Bantry Bay Pharmac's FEI number is 3004128564.
What types of violations has Bantry Bay Pharmac received?
Bantry Bay Pharmac has been cited for 2 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 Bantry Bay Pharmac come from?
All FDA import refusal data for Bantry Bay Pharmac 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.