Accord Healthcare, Inc.
⚠️ Moderate Risk
FEI: 3007518432 • Durham, NC • UNITED STATES
FEI Number
3007518432
Location
Durham, NC
Country
UNITED STATESAddress
1009 Slater Rd Ste 210B, , 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).
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2022 | 64BDY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2021 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 10/8/2020 | 64LDY40HYDROCORTISONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/1/2013 | 56HYP45MITOMYCIN (ANTITUMOR) | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Accord Healthcare, Inc.'s FDA import refusal history?
Accord Healthcare, Inc. (FEI: 3007518432) has 4 FDA import refusal record(s) in our database, spanning from 7/1/2013 to 9/1/2022.
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. Accord Healthcare, Inc.'s FEI number is 3007518432.
What types of violations has Accord Healthcare, Inc. received?
Accord Healthcare, Inc. has been cited for 4 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 Accord Healthcare, Inc. come from?
All FDA import refusal data for Accord Healthcare, 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.