Professional Disposables International, Inc.
⚠️ Moderate Risk
FEI: 2411192 • Orangeburg, NY • UNITED STATES
FEI Number
2411192
Location
Orangeburg, NY
Country
UNITED STATESAddress
2 Nice Pak Park, , Orangeburg, NY, United States
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).
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.
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 |
|---|---|---|---|
| 8/5/2014 | 80LRJDISINFECTANT, MEDICAL DEVICES | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/6/2014 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | New England District Office (NWE-DO) | |
| 8/10/2011 | 62FAL34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 62FBL08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/21/2011 | 62FAL34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/17/2011 | 62FBL08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/8/2011 | 62FBL34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/27/2010 | 62FBJ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/27/2010 | 62FBJ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/13/2009 | 64AAY16THIOSALAN (DISINFECTANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 97RAFCLEANER, ULTRASONIC NON-MEDICAL DEVICES | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Professional Disposables International, Inc.'s FDA import refusal history?
Professional Disposables International, Inc. (FEI: 2411192) has 11 FDA import refusal record(s) in our database, spanning from 3/12/2009 to 8/5/2014.
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. Professional Disposables International, Inc.'s FEI number is 2411192.
What types of violations has Professional Disposables International, Inc. received?
Professional Disposables International, Inc. has been cited for 3 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 Professional Disposables International, Inc. come from?
All FDA import refusal data for Professional Disposables International, Inc. 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.