James A Barry & Co Ltd
⚠️ Moderate Risk
FEI: 3003046427 • Co. Cork • IRELAND
FEI Number
3003046427
Location
Co. Cork
Country
IRELANDAddress
Upper Quartertown, , Mellow, Co. Cork, , Ireland
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/15/2009 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New York District Office (NYK-DO) | |
| 1/15/2009 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/6/2007 | 60LBO99ANALGESIC, N.E.C. | New York District Office (NYK-DO) | |
| 3/6/2007 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 3/6/2007 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 3/6/2007 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 10/28/2005 | 37JCE99SAUCES, N.E.C. | 62NEEDS FCE | New York District Office (NYK-DO) |
| 11/5/2004 | 33GGT03FONDANT CANDY BAR, SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE) | 274COLOR LBLG | New York District Office (NYK-DO) |
| 11/5/2004 | 33GGT03FONDANT CANDY BAR, SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE) | 274COLOR LBLG | New York District Office (NYK-DO) |
| 11/5/2004 | 33GGT03FONDANT CANDY BAR, SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE) | 274COLOR LBLG | New York District Office (NYK-DO) |
| 11/5/2004 | 33GGT03FONDANT CANDY BAR, SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE) | 274COLOR LBLG | New York District Office (NYK-DO) |
| 6/9/2003 | 60SAR99ANTACID, N.E.C. | New York District Office (NYK-DO) | |
| 3/21/2003 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is James A Barry & Co Ltd's FDA import refusal history?
James A Barry & Co Ltd (FEI: 3003046427) has 13 FDA import refusal record(s) in our database, spanning from 3/21/2003 to 1/15/2009.
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. James A Barry & Co Ltd's FEI number is 3003046427.
What types of violations has James A Barry & Co Ltd received?
James A Barry & Co Ltd 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 James A Barry & Co Ltd come from?
All FDA import refusal data for James A Barry & Co 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.