Siegranz Chemworks Corporation
⚠️ Moderate Risk
FEI: 3008397119 • Las Pinas, National Capital Region (Manil • PHILIPPINES
FEI Number
3008397119
Location
Las Pinas, National Capital Region (Manil
Country
PHILIPPINESAddress
15-B Sapphire St. DBP Farmroad, , Las Pinas, National Capital Region (Manil, Philippines
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).
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.
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).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/8/2011 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 3/8/2011 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Siegranz Chemworks Corporation's FDA import refusal history?
Siegranz Chemworks Corporation (FEI: 3008397119) has 2 FDA import refusal record(s) in our database, spanning from 3/8/2011 to 3/8/2011.
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. Siegranz Chemworks Corporation's FEI number is 3008397119.
What types of violations has Siegranz Chemworks Corporation received?
Siegranz Chemworks Corporation 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 Siegranz Chemworks Corporation come from?
All FDA import refusal data for Siegranz Chemworks Corporation 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.