Pineda Laboratorio
⚠️ Moderate Risk
FEI: 3004113802 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3004113802
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Monte Alegre 1142, , Sao Paulo, Sao Paulo, Brazil
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2015 | 66VDP99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 3/19/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/25/2004 | 62FCJ99ANTI-INFECTIVE, TOPICAL N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/25/2004 | 60QCL46PROCAINE HCL (ANESTHETIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pineda Laboratorio's FDA import refusal history?
Pineda Laboratorio (FEI: 3004113802) has 4 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 4/14/2015.
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. Pineda Laboratorio's FEI number is 3004113802.
What types of violations has Pineda Laboratorio received?
Pineda Laboratorio 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 Pineda Laboratorio come from?
All FDA import refusal data for Pineda Laboratorio 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.