Apitoria Pharma Private Limited
⚠️ Moderate Risk
FEI: 3004611182 • Pydibhimavaram, Andhra Pradesh • INDIA
FEI Number
3004611182
Location
Pydibhimavaram, Andhra Pradesh
Country
INDIAAddress
2 4to9 11 29 30 31&32 Sy No'S 52, Unit - Iv; Sy No 1; 53 58 59 61 - 78 127&128 Ranasthalam Mandal, Pydibhimavaram, Andhra Pradesh, India
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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/17/2022 | 61PCY62PIOGLITAZONE HCL | Division of Southeast Imports (DSEI) | |
| 6/3/2014 | 66NCS05ZIPRASIDONE HCI (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 12/19/2012 | 62OCZ15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/12/2012 | 62VCZ43ZIDOVUDINE (ANTI-VIRAL) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Apitoria Pharma Private Limited's FDA import refusal history?
Apitoria Pharma Private Limited (FEI: 3004611182) has 4 FDA import refusal record(s) in our database, spanning from 10/12/2012 to 2/17/2022.
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. Apitoria Pharma Private Limited's FEI number is 3004611182.
What types of violations has Apitoria Pharma Private Limited received?
Apitoria Pharma Private Limited 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 Apitoria Pharma Private Limited come from?
All FDA import refusal data for Apitoria Pharma Private Limited 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.