Penn Pharmaceutical Services Limited
⚠️ Moderate Risk
FEI: 1000370240 • Tredegar, Gwent • UNITED KINGDOM
FEI Number
1000370240
Location
Tredegar, Gwent
Country
UNITED KINGDOMAddress
Unit 23-24, Tafarnaubach Industrial Estate, Tredegar, Gwent, 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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2018 | 62IIA99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/8/2016 | 87OYRFILLER, BONE VOID, RECOMBINANT PLATELET-DERIVED GROWTH FACTOR | Division of Northern Border Imports (DNBI) | |
| 9/14/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/7/2011 | 55RP48COMPRESSIBLE SUGAR (PHARMACEUTIC NECESSITY - TABLET EXCIPIENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/8/2009 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/31/2009 | 61LIY34ARGATROBAN (ANTI-COAGULANT) | Cincinnati District Office (CIN-DO) | |
| 3/21/2006 | 61MIS99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/22/2004 | 64TDA01AZATHIOPRINE (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Penn Pharmaceutical Services Limited's FDA import refusal history?
Penn Pharmaceutical Services Limited (FEI: 1000370240) has 8 FDA import refusal record(s) in our database, spanning from 10/22/2004 to 8/20/2018.
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. Penn Pharmaceutical Services Limited's FEI number is 1000370240.
What types of violations has Penn Pharmaceutical Services Limited received?
Penn Pharmaceutical Services Limited has been cited for 7 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 Penn Pharmaceutical Services Limited come from?
All FDA import refusal data for Penn Pharmaceutical Services 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.