Pen Pak Co
⚠️ Moderate Risk
FEI: 3000268278 • Bangkok • THAILAND
FEI Number
3000268278
Location
Bangkok
Country
THAILANDAddress
22 Tanon Sampaya, , Bangkok, , Thailand
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).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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).
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).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
ALCOHOL
The article appears to be a confectionary that bears or contains alcohol in excess of 1/2 of 1% by volume derived solely from the use of flavoring extracts.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/25/2008 | 54ECT99HERBALS & BOTANICAL TEAS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/25/2008 | 54ECT99HERBALS & BOTANICAL TEAS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/7/2006 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/25/2005 | 54ECK99HERBALS & BOTANICAL TEAS, N.E.C. | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 7/25/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 7/23/2005 | 54ECT99HERBALS & BOTANICAL TEAS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/13/2005 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 54ECT99HERBALS & BOTANICAL TEAS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/27/2004 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pen Pak Co's FDA import refusal history?
Pen Pak Co (FEI: 3000268278) has 9 FDA import refusal record(s) in our database, spanning from 9/27/2004 to 2/25/2008.
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. Pen Pak Co's FEI number is 3000268278.
What types of violations has Pen Pak Co received?
Pen Pak Co has been cited for 9 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 Pen Pak Co come from?
All FDA import refusal data for Pen Pak Co 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.