Central Admixture Pharmacy Inc.
⚠️ Moderate Risk
FEI: 1000165314 • Bethlehem, PA • UNITED STATES
FEI Number
1000165314
Location
Bethlehem, PA
Country
UNITED STATESAddress
824 12th Ave, , Bethlehem, PA, United States
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
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2012 | 55RP74DEXTROSE (PHARMACEUTIC NECESSITY) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/2/2012 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/4/2008 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Chicago District Office (CHI-DO) | |
| 5/23/2008 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Chicago District Office (CHI-DO) | |
| 8/23/2004 | 79GBACATHETER, BALLOON TYPE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Central Admixture Pharmacy Inc.'s FDA import refusal history?
Central Admixture Pharmacy Inc. (FEI: 1000165314) has 5 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 11/2/2012.
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. Central Admixture Pharmacy Inc.'s FEI number is 1000165314.
What types of violations has Central Admixture Pharmacy Inc. received?
Central Admixture Pharmacy Inc. has been cited for 4 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 Central Admixture Pharmacy Inc. come from?
All FDA import refusal data for Central Admixture Pharmacy Inc. 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.