Parker Laboratories, Inc.
⚠️ Moderate Risk
FEI: 2212018 • Fairfield, NJ • UNITED STATES
FEI Number
2212018
Location
Fairfield, NJ
Country
UNITED STATESAddress
286 Eldridge Rd, , Fairfield, 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
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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2023 | 84GYBMEDIA, ELECTROCONDUCTIVE | Division of Southeast Imports (DSEI) | |
| 6/9/2023 | 84GYBMEDIA, ELECTROCONDUCTIVE | Division of Southeast Imports (DSEI) | |
| 6/23/2016 | 84GYBMEDIA, ELECTROCONDUCTIVE | New Orleans District Office (NOL-DO) | |
| 10/31/2011 | 84GYBMEDIA, ELECTROCONDUCTIVE | 336INCONSPICU | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Parker Laboratories, Inc.'s FDA import refusal history?
Parker Laboratories, Inc. (FEI: 2212018) has 4 FDA import refusal record(s) in our database, spanning from 10/31/2011 to 6/22/2023.
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. Parker Laboratories, Inc.'s FEI number is 2212018.
What types of violations has Parker Laboratories, Inc. received?
Parker Laboratories, Inc. has been cited for 5 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 Parker Laboratories, Inc. come from?
All FDA import refusal data for Parker 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.