Sharp Clinical Services Inc.
⚠️ Moderate Risk
FEI: 1000522668 • Phoenixville, PA • UNITED STATES
FEI Number
1000522668
Location
Phoenixville, PA
Country
UNITED STATESAddress
300 Kimberton Rd, , Phoenixville, 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.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
Frequently Asked Questions
What is Sharp Clinical Services Inc.'s FDA import refusal history?
Sharp Clinical Services Inc. (FEI: 1000522668) has 2 FDA import refusal record(s) in our database, spanning from 2/2/2006 to 8/22/2008.
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. Sharp Clinical Services Inc.'s FEI number is 1000522668.
What types of violations has Sharp Clinical Services Inc. received?
Sharp Clinical Services Inc. 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 Sharp Clinical Services Inc. come from?
All FDA import refusal data for Sharp Clinical Services 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.