ALPHA CHEMIKA
⚠️ Moderate Risk
FEI: 3013927840 • Mumbai • INDIA
FEI Number
3013927840
Location
Mumbai
Country
INDIAAddress
102 1f B Wing Savgan He, , Mumbai, , 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
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 |
|---|---|---|---|
| 8/5/2020 | 88HYHGOLD CHLORIDE | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88LEFSTAINS, DYE POWDER | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88LEFSTAINS, DYE POWDER | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 83JTSSTAINS, MICROBIOLOGIC | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88KKQSODIUM PERIODATE | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88HYQIRON CHLORIDE-WEIGERT | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88KFCMETHYLENE BLUE, TISSUE STAIN | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88IABTOLUIDINE BLUE | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88IABTOLUIDINE BLUE | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88IABTOLUIDINE BLUE | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88ICLCARBOL FUCHSIN | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88ICFCRYSTAL VIOLET FOR HISTOLOGY | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88LEFSTAINS, DYE POWDER | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88LEFSTAINS, DYE POWDER | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88KKSACID, PERIODIC | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88KFDANILINE BLUE | Division of Southeast Imports (DSEI) | |
| 8/5/2020 | 88IDAALCIAN BLUE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ALPHA CHEMIKA's FDA import refusal history?
ALPHA CHEMIKA (FEI: 3013927840) has 17 FDA import refusal record(s) in our database, spanning from 8/5/2020 to 8/5/2020.
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. ALPHA CHEMIKA's FEI number is 3013927840.
What types of violations has ALPHA CHEMIKA received?
ALPHA CHEMIKA 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 ALPHA CHEMIKA come from?
All FDA import refusal data for ALPHA CHEMIKA 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.