Baxter Heathcare Ltd
⚠️ Moderate Risk
FEI: 1000261013 • Thetford, Norfolk • UNITED KINGDOM
FEI Number
1000261013
Location
Thetford, Norfolk
Country
UNITED KINGDOMAddress
Caxton Way, , Thetford, Norfolk, United Kingdom
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).
FDF4APIGMP
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/15/2018 | 65RCP04CALCIUM GLUCONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 2/15/2018 | 65RCP04CALCIUM GLUCONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 2/15/2018 | 65RCP04CALCIUM GLUCONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 7/27/2016 | 65RIK99REPLENISHER N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/21/2012 | 62IDP83IFOSFAMIDE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/4/2002 | 78FDJSNARE, RIGID SELF-OPENING | 126FAILS STD | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Baxter Heathcare Ltd's FDA import refusal history?
Baxter Heathcare Ltd (FEI: 1000261013) has 6 FDA import refusal record(s) in our database, spanning from 3/4/2002 to 2/15/2018.
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. Baxter Heathcare Ltd's FEI number is 1000261013.
What types of violations has Baxter Heathcare Ltd received?
Baxter Heathcare Ltd 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 Baxter Heathcare Ltd come from?
All FDA import refusal data for Baxter Heathcare Ltd 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.