AKRON FORMULATIONS INDIA PRIVATE LIMITED
⚠️ High Risk
FEI: 3017000602 • Hyderabad, Telangana • INDIA
FEI Number
3017000602
Location
Hyderabad, Telangana
Country
INDIAAddress
134 - B Meyapur-Bolaram, , Hyderabad, Telangana, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/6/2025 | 63HAL22SENNA (CATHARTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/6/2025 | 63HAL22SENNA (CATHARTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/6/2025 | 61XJL18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/6/2025 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/6/2025 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/6/2025 | 60LAL01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/6/2025 | 60LAL01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/15/2025 | 60LAA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 1/15/2025 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/15/2025 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/15/2025 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/13/2025 | 60LAL01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/13/2025 | 60LAL01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/13/2025 | 60LAL01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/20/2024 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/20/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/20/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/20/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/20/2024 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/20/2024 | 60LAL01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/20/2024 | 63HAL22SENNA (CATHARTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/20/2024 | 63HAL22SENNA (CATHARTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is AKRON FORMULATIONS INDIA PRIVATE LIMITED's FDA import refusal history?
AKRON FORMULATIONS INDIA PRIVATE LIMITED (FEI: 3017000602) has 22 FDA import refusal record(s) in our database, spanning from 12/20/2024 to 2/6/2025.
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. AKRON FORMULATIONS INDIA PRIVATE LIMITED's FEI number is 3017000602.
What types of violations has AKRON FORMULATIONS INDIA PRIVATE LIMITED received?
AKRON FORMULATIONS INDIA PRIVATE LIMITED 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 AKRON FORMULATIONS INDIA PRIVATE LIMITED come from?
All FDA import refusal data for AKRON FORMULATIONS INDIA 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.