Almac Clinical Services LLC
⚠️ Moderate Risk
FEI: 3008822909 • Durham, NC • UNITED STATES
FEI Number
3008822909
Location
Durham, NC
Country
UNITED STATESAddress
4228 Technology Dr, , Durham, NC, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/20/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/22/2010 | 66YIF99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/29/2007 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/5/2007 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2007 | 63XIS99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/27/2007 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2007 | 63XIS99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/18/2005 | 62ICB80GEMCITABINE HCL (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VCI99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Almac Clinical Services LLC's FDA import refusal history?
Almac Clinical Services LLC (FEI: 3008822909) has 9 FDA import refusal record(s) in our database, spanning from 8/18/2003 to 7/20/2015.
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. Almac Clinical Services LLC's FEI number is 3008822909.
What types of violations has Almac Clinical Services LLC received?
Almac Clinical Services 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 Almac Clinical Services LLC come from?
All FDA import refusal data for Almac Clinical Services 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.