Cyan Labs, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3010873298 • Ciudad Apodaca, Nuevo Leon • MEXICO
FEI Number
3010873298
Location
Ciudad Apodaca, Nuevo Leon
Country
MEXICOAddress
Anillo Periferico Km. 37, Col. Moises Saenz, Apodaca, Ciudad Apodaca, Nuevo Leon, Mexico
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Cyan Labs, S.A. de C.V.'s FDA import refusal history?
Cyan Labs, S.A. de C.V. (FEI: 3010873298) has 3 FDA import refusal record(s) in our database, spanning from 4/16/2020 to 11/19/2020.
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. Cyan Labs, S.A. de C.V.'s FEI number is 3010873298.
What types of violations has Cyan Labs, S.A. de C.V. received?
Cyan Labs, S.A. de C.V. 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 Cyan Labs, S.A. de C.V. come from?
All FDA import refusal data for Cyan Labs, S.A. de C.V. 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.