Maeil Dairies Co., Ltd- GWANGJU PLANT
⚠️ High Risk
FEI: 3003702438 • Gwangsan-Ku • SOUTH KOREA
FEI
FEI Number
3003702438
📍
Location
Gwangsan-Ku
🇰🇷
Country
SOUTH KOREA🏢
Address
Gwanju Metro City, Eodeung-Daero, Gwangsan-Ku, , South Korea
High Risk
FDA Import Risk Assessment
64.4
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
103
Total Refusals
2
Unique Violations
5/6/2004
Latest Refusal
2/18/2003
Earliest Refusal
Score Breakdown
Violation Severity
80.0×40%
Refusal Volume
74.7×30%
Recency
0.0×20%
Frequency
100.0×10%
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
8383×
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
6231×
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/6/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/5/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/20/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/20/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/20/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/20/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/19/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/19/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/19/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/19/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/19/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/19/2004 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 12/9/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 12/9/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 12/9/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 12/9/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/1/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/1/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/1/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/1/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/1/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/1/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/1/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/1/2003 | 24DFE13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/18/2003 | 24DFT13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/18/2003 | 24DFT13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/18/2003 | 24DFT13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/18/2003 | 24DFT13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/18/2003 | 24DFT13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD'), JUICE OR DRINK | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Maeil Dairies Co., Ltd- GWANGJU PLANT's FDA import refusal history?
Maeil Dairies Co., Ltd- GWANGJU PLANT (FEI: 3003702438) has 103 FDA import refusal record(s) in our database, spanning from 2/18/2003 to 5/6/2004.
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. Maeil Dairies Co., Ltd- GWANGJU PLANT's FEI number is 3003702438.
What types of violations has Maeil Dairies Co., Ltd- GWANGJU PLANT received?
Maeil Dairies Co., Ltd- GWANGJU PLANT 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 Maeil Dairies Co., Ltd- GWANGJU PLANT come from?
All FDA import refusal data for Maeil Dairies Co., Ltd- GWANGJU PLANT 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.