Arista Latindo Industrial, Ltd. P.T.
⚠️ Moderate Risk
FEI: 3002166545 • Jakarta Barat • INDONESIA
FEI Number
3002166545
Location
Jakarta Barat
Country
INDONESIAAddress
Jalan Kyai Haji Muhammad 128, , Jakarta Barat, , Indonesia
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/27/2008 | 16SGT37SNAPPER (RED, GRAY, MALABAR, ETC.), COLD SMOKED, FISH | 249FILTHY | New England District Office (NWE-DO) |
| 6/27/2008 | 16AGT37SNAPPER (RED, GRAY, MALABAR, ETC.) | 249FILTHY | New England District Office (NWE-DO) |
| 6/27/2008 | 16AGT37SNAPPER (RED, GRAY, MALABAR, ETC.) | 249FILTHY | New England District Office (NWE-DO) |
| 6/27/2008 | 16AGT37SNAPPER (RED, GRAY, MALABAR, ETC.) | 249FILTHY | New England District Office (NWE-DO) |
| 6/27/2008 | 16AGT37SNAPPER (RED, GRAY, MALABAR, ETC.) | 249FILTHY | New England District Office (NWE-DO) |
| 6/27/2008 | 16AGT37SNAPPER (RED, GRAY, MALABAR, ETC.) | 249FILTHY | New England District Office (NWE-DO) |
| 6/27/2008 | 16AGT37SNAPPER (RED, GRAY, MALABAR, ETC.) | 249FILTHY | New England District Office (NWE-DO) |
| 4/8/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 2/12/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 2/12/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 2/12/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 2/12/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 2/12/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 2/12/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 2/12/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 10/15/2001 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Arista Latindo Industrial, Ltd. P.T.'s FDA import refusal history?
Arista Latindo Industrial, Ltd. P.T. (FEI: 3002166545) has 16 FDA import refusal record(s) in our database, spanning from 10/15/2001 to 6/27/2008.
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. Arista Latindo Industrial, Ltd. P.T.'s FEI number is 3002166545.
What types of violations has Arista Latindo Industrial, Ltd. P.T. received?
Arista Latindo Industrial, Ltd. P.T. has been cited for 5 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 Arista Latindo Industrial, Ltd. P.T. come from?
All FDA import refusal data for Arista Latindo Industrial, Ltd. P.T. 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.