Acon Laboratories, Inc.
⚠️ Moderate Risk
FEI: 3003516723 • San Diego, CA • UNITED STATES
FEI Number
3003516723
Location
San Diego, CA
Country
UNITED STATESAddress
10125 Mesa Rim Rd, , San Diego, CA, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 8/8/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/28/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/28/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/3/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/3/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/3/2002 | 91MVOKIT, TEST, MULTIPLE DRUGS OF ABUSE, OVER THE COUNTER | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 12/3/2002 | 75MPQSPECIMEN CONTAINER, URINE, DRUGS OF ABUSE, OVER THE COUNTER | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Acon Laboratories, Inc.'s FDA import refusal history?
Acon Laboratories, Inc. (FEI: 3003516723) has 7 FDA import refusal record(s) in our database, spanning from 12/3/2002 to 8/8/2022.
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. Acon Laboratories, Inc.'s FEI number is 3003516723.
What types of violations has Acon Laboratories, Inc. received?
Acon 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 Acon Laboratories, Inc. come from?
All FDA import refusal data for Acon 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.