LABORATORIES BIO & Ha. S. A. DE CV.
⚠️ Moderate Risk
FEI: 3005254542 • Poblado Comunal Cancun, Tabasco • MEXICO
FEI Number
3005254542
Location
Poblado Comunal Cancun, Tabasco
Country
MEXICOAddress
Unknown, Balancan, Poblado Comunal Cancun, Tabasco, 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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2005 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | San Francisco District Office (SAN-DO) | |
| 8/19/2005 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | San Francisco District Office (SAN-DO) | |
| 8/19/2005 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | San Francisco District Office (SAN-DO) | |
| 8/19/2005 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | San Francisco District Office (SAN-DO) | |
| 8/19/2005 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is LABORATORIES BIO & Ha. S. A. DE CV.'s FDA import refusal history?
LABORATORIES BIO & Ha. S. A. DE CV. (FEI: 3005254542) has 5 FDA import refusal record(s) in our database, spanning from 8/19/2005 to 8/19/2005.
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. LABORATORIES BIO & Ha. S. A. DE CV.'s FEI number is 3005254542.
What types of violations has LABORATORIES BIO & Ha. S. A. DE CV. received?
LABORATORIES BIO & Ha. S. A. DE CV. 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 LABORATORIES BIO & Ha. S. A. DE CV. come from?
All FDA import refusal data for LABORATORIES BIO & Ha. S. A. DE CV. 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.