Peter Thomas Roth Labs, LLC
✅ Low Risk
FEI: 3002735976 • New York, NY • UNITED STATES
FEI Number
3002735976
Location
New York, NY
Country
UNITED STATESAddress
400 Park Ave Fl 14, , New York, NY, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is Peter Thomas Roth Labs, LLC's FDA import refusal history?
Peter Thomas Roth Labs, LLC (FEI: 3002735976) has 1 FDA import refusal record(s) in our database, spanning from 11/25/2011 to 11/25/2011.
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. Peter Thomas Roth Labs, LLC's FEI number is 3002735976.
What types of violations has Peter Thomas Roth Labs, LLC received?
Peter Thomas Roth Labs, LLC has been cited for 3 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 Peter Thomas Roth Labs, LLC come from?
All FDA import refusal data for Peter Thomas Roth Labs, 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.