Acme Generics Private Limited
⚠️ High Risk
FEI: 3012112224 • Solan, Himachal Pradesh • INDIA
FEI Number
3012112224
Location
Solan, Himachal Pradesh
Country
INDIAAddress
Plot No. 115, Hpsidc Industrial Area Davni, P.O. Gurumajra, Tehsil Nalagarh, , Solan, Himachal Pradesh, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2025 | 66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | Division of Southeast Imports (DSEI) | |
| 3/26/2025 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 12/10/2024 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2024 | 62GCA99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/29/2023 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2023 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2023 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2023 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2023 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2022 | 61NCA23DOTHIEPIN HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2021 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2021 | 60LDA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2021 | 60LDA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2021 | 66JDA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2021 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2020 | 56MDA01AZTREONAM (BACTAM (B-LACTAM ANTIBIOTIC)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2020 | 56MDA01AZTREONAM (BACTAM (B-LACTAM ANTIBIOTIC)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2020 | 61NDB23DOTHIEPIN HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 66JCY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/30/2020 | 63HCA99CATHARTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 66JDB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2020 | 66JCY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/22/2020 | 65NBC46LIOTHYRONINE I 125 (RADIOACTIVE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2019 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2019 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/6/2019 | 66BCB99STIMULANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/24/2019 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/5/2019 | 66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/27/2019 | 66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 61NCA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/25/2019 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 66JCY99THYROID HORMONE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 61NCY23DOTHIEPIN HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Acme Generics Private Limited's FDA import refusal history?
Acme Generics Private Limited (FEI: 3012112224) has 35 FDA import refusal record(s) in our database, spanning from 4/30/2018 to 7/11/2025.
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. Acme Generics Private Limited's FEI number is 3012112224.
What types of violations has Acme Generics Private Limited received?
Acme Generics 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 Acme Generics Private Limited come from?
All FDA import refusal data for Acme Generics 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.