Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P.
⚠️ High Risk
FEI: 1950222 • Saint Louis, MO • UNITED STATES
FEI Number
1950222
Location
Saint Louis, MO
Country
UNITED STATESAddress
1945 Craig Rd, , Saint Louis, MO, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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 |
|---|---|---|---|
| 4/19/2011 | 60CIK04EPINEPHRINE (ADRENERGIC) | Detroit District Office (DET-DO) | |
| 4/19/2011 | 61EIA08LORATADINE (ANTI-ASTHMATIC) | Detroit District Office (DET-DO) | |
| 4/19/2011 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | Detroit District Office (DET-DO) | |
| 4/19/2011 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | Detroit District Office (DET-DO) | |
| 4/19/2011 | 60CCY04EPINEPHRINE (ADRENERGIC) | Detroit District Office (DET-DO) | |
| 4/19/2011 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | Detroit District Office (DET-DO) | |
| 4/19/2011 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/19/2011 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/19/2011 | 60CCY04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/19/2011 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/19/2011 | 60CCY04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/19/2011 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P.'s FDA import refusal history?
Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. (FEI: 1950222) has 12 FDA import refusal record(s) in our database, spanning from 4/19/2011 to 4/19/2011.
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. Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P.'s FEI number is 1950222.
What types of violations has Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. received?
Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. 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 Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. come from?
All FDA import refusal data for Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. 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.