Lindberg Ag A4 Branch
✅ Low Risk
FEI: 3005819951 • Olongapo City, Central Luzon • PHILIPPINES
FEI Number
3005819951
Location
Olongapo City, Central Luzon
Country
PHILIPPINESAddress
Lot #5 . Boton Light And Science Park, Argonaut Highway, Olongapo City, Central Luzon, Philippines
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/25/2022 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 7/25/2022 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 7/25/2022 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Lindberg Ag A4 Branch's FDA import refusal history?
Lindberg Ag A4 Branch (FEI: 3005819951) has 3 FDA import refusal record(s) in our database, spanning from 7/25/2022 to 7/25/2022.
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. Lindberg Ag A4 Branch's FEI number is 3005819951.
What types of violations has Lindberg Ag A4 Branch received?
Lindberg Ag A4 Branch has been cited for 1 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 Lindberg Ag A4 Branch come from?
All FDA import refusal data for Lindberg Ag A4 Branch 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.