PPL Healthcare LLC
⚠️ Moderate Risk
FEI: 2517175 • Sellersville, PA • UNITED STATES
FEI Number
2517175
Location
Sellersville, PA
Country
UNITED STATESAddress
650 Cathill Rd, , Sellersville, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/26/2016 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/20/2012 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Florida District Office (FLA-DO) |
| 6/29/2012 | 62OCA15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/14/2008 | 64LCJ28FLUOCINONIDE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 12/23/2003 | 62KCH08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 179AGR RX | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is PPL Healthcare LLC's FDA import refusal history?
PPL Healthcare LLC (FEI: 2517175) has 5 FDA import refusal record(s) in our database, spanning from 12/23/2003 to 1/26/2016.
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. PPL Healthcare LLC's FEI number is 2517175.
What types of violations has PPL Healthcare LLC received?
PPL Healthcare LLC 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 PPL Healthcare LLC come from?
All FDA import refusal data for PPL Healthcare LLC 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.