Piramal Healthcare UK Limited
⚠️ High Risk
FEI: 3002808116 • Morpeth, Northumberland • UNITED KINGDOM
FEI Number
3002808116
Location
Morpeth, Northumberland
Country
UNITED KINGDOMAddress
Whalton Road, , Morpeth, Northumberland, United Kingdom
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2025 | 65KCA09MISOPROSTOL (PROSTAGLANDIN) | Division of Southeast Imports (DSEI) | |
| 7/28/2013 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 2/3/2011 | 62GCS99ANTI-INFLAMMATORY N.E.C. | Chicago District Office (CHI-DO) | |
| 3/17/2008 | 62GCS99ANTI-INFLAMMATORY N.E.C. | Chicago District Office (CHI-DO) | |
| 3/17/2008 | 62GCS99ANTI-INFLAMMATORY N.E.C. | Chicago District Office (CHI-DO) | |
| 3/17/2008 | 62GCS99ANTI-INFLAMMATORY N.E.C. | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Piramal Healthcare UK Limited's FDA import refusal history?
Piramal Healthcare UK Limited (FEI: 3002808116) has 6 FDA import refusal record(s) in our database, spanning from 3/17/2008 to 7/16/2025.
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. Piramal Healthcare UK Limited's FEI number is 3002808116.
What types of violations has Piramal Healthcare UK Limited received?
Piramal Healthcare UK Limited has been cited for 5 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 Piramal Healthcare UK Limited come from?
All FDA import refusal data for Piramal Healthcare UK Limited 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.