Pt. Shamrock Manufacturing Corp.
⚠️ High Risk
FEI: 3003958472 • N. Sumatra • INDONESIA
FEI Number
3003958472
Location
N. Sumatra
Country
INDONESIAAddress
Namorambe PS.IV Km.9, Jalan Raya Medan, Kab. Deli Serdang, N. Sumatra, , Indonesia
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
FILTH
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/17/2024 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of West Coast Imports (DWCI) | |
| 3/18/2014 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Northeast Imports (DNEI) |
| 3/12/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Northeast Imports (DNEI) |
| 3/12/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Northeast Imports (DNEI) |
| 7/21/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Pt. Shamrock Manufacturing Corp.'s FDA import refusal history?
Pt. Shamrock Manufacturing Corp. (FEI: 3003958472) has 5 FDA import refusal record(s) in our database, spanning from 7/21/2009 to 1/17/2024.
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. Pt. Shamrock Manufacturing Corp.'s FEI number is 3003958472.
What types of violations has Pt. Shamrock Manufacturing Corp. received?
Pt. Shamrock Manufacturing Corp. has been cited for 4 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 Pt. Shamrock Manufacturing Corp. come from?
All FDA import refusal data for Pt. Shamrock Manufacturing Corp. 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.