INDUSTRIAL CLOTHINGS (PVT) LTD.
⚠️ High Risk
FEI: 3012355534 • Avissawella Western, Colombo • SRI LANKA
FEI Number
3012355534
Location
Avissawella Western, Colombo
Country
SRI LANKAAddress
Prime Polymers Division, D17, Seethawaka Export Processing Zone, Avissawella Western, Colombo, Sri Lanka
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.
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.
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.
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 9/10/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 9/10/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 9/10/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 9/10/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/24/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/24/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/15/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/10/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) | |
| 8/10/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Southeast Imports (DSEI) | |
| 7/17/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 7/17/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) | |
| 7/17/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Southeast Imports (DSEI) | |
| 7/17/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Southeast Imports (DSEI) | |
| 7/17/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) | |
| 7/3/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) | |
| 6/26/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) | |
| 5/15/2018 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is INDUSTRIAL CLOTHINGS (PVT) LTD.'s FDA import refusal history?
INDUSTRIAL CLOTHINGS (PVT) LTD. (FEI: 3012355534) has 23 FDA import refusal record(s) in our database, spanning from 5/15/2018 to 1/16/2019.
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. INDUSTRIAL CLOTHINGS (PVT) LTD.'s FEI number is 3012355534.
What types of violations has INDUSTRIAL CLOTHINGS (PVT) LTD. received?
INDUSTRIAL CLOTHINGS (PVT) LTD. has been cited for 6 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 INDUSTRIAL CLOTHINGS (PVT) LTD. come from?
All FDA import refusal data for INDUSTRIAL CLOTHINGS (PVT) LTD. 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.