Anidro Do Brasil Extracoes S.A.
⚠️ Moderate Risk
FEI: 3002807563 • Parnaiba, Piaui • BRAZIL
FEI Number
3002807563
Location
Parnaiba, Piaui
Country
BRAZILAddress
Rua Pilocarpina 1000, , Parnaiba, Piaui, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/10/2018 | 63NIS21PILOCARPINE HCL (CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/30/2014 | 63NCY21PILOCARPINE HCL (CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2012 | 63NCS21PILOCARPINE HCL (CHOLINERGIC) | Chicago District Office (CHI-DO) | |
| 11/1/2012 | 63NCS21PILOCARPINE HCL (CHOLINERGIC) | Chicago District Office (CHI-DO) | |
| 8/12/2011 | 63NIL22PILOCARPINE NITRATE (CHOLINERGIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Anidro Do Brasil Extracoes S.A.'s FDA import refusal history?
Anidro Do Brasil Extracoes S.A. (FEI: 3002807563) has 5 FDA import refusal record(s) in our database, spanning from 8/12/2011 to 8/10/2018.
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. Anidro Do Brasil Extracoes S.A.'s FEI number is 3002807563.
What types of violations has Anidro Do Brasil Extracoes S.A. received?
Anidro Do Brasil Extracoes S.A. 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 Anidro Do Brasil Extracoes S.A. come from?
All FDA import refusal data for Anidro Do Brasil Extracoes S.A. 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.