Robert Reid Cabral Chidrens Hosp
⚠️ Moderate Risk
FEI: 3004613536 • Santo Dominco • DOMINICAN REPUBLIC
FEI Number
3004613536
Location
Santo Dominco
Country
DOMINICAN REPUBLICAddress
2 Abraham Lincoln Centro De Los, , Santo Dominco, , Dominican Republic
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/31/2004 | 56BAY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 56IAY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 80KZHINTRODUCER, SYRINGE NEEDLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Robert Reid Cabral Chidrens Hosp's FDA import refusal history?
Robert Reid Cabral Chidrens Hosp (FEI: 3004613536) has 4 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 8/31/2004.
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. Robert Reid Cabral Chidrens Hosp's FEI number is 3004613536.
What types of violations has Robert Reid Cabral Chidrens Hosp received?
Robert Reid Cabral Chidrens Hosp 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 Robert Reid Cabral Chidrens Hosp come from?
All FDA import refusal data for Robert Reid Cabral Chidrens Hosp 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.