Able Laboratories Inc.
⚠️ Moderate Risk
FEI: 2245394 • S Plainfield, NJ • UNITED STATES
FEI Number
2245394
Location
S Plainfield, NJ
Country
UNITED STATESAddress
6 Hollywood Ct, , S Plainfield, NJ, 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/30/2004 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 3/12/2004 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
| 3/12/2004 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
| 8/27/2003 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
| 8/27/2003 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
| 6/26/2003 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
| 5/1/2003 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
| 5/1/2003 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
| 3/31/2003 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
| 3/31/2003 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 12/3/2002 | 66SCA28NITROGLYCERIN (TAB) (VASODILATOR) | 179AGR RX | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Able Laboratories Inc.'s FDA import refusal history?
Able Laboratories Inc. (FEI: 2245394) has 11 FDA import refusal record(s) in our database, spanning from 12/3/2002 to 7/30/2004.
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. Able Laboratories Inc.'s FEI number is 2245394.
What types of violations has Able Laboratories Inc. received?
Able Laboratories 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 Able Laboratories Inc. come from?
All FDA import refusal data for Able Laboratories 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.