Stalder Laboratiories
⚠️ Moderate Risk
FEI: 3007094293 • San Isidro, Davao Region • PHILIPPINES
FEI Number
3007094293
Location
San Isidro, Davao Region
Country
PHILIPPINESAddress
4 Region, San Pablo Laguna, San Isidro, Davao Region, 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
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/1/2013 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/19/2012 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/19/2012 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/19/2012 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/19/2012 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/19/2012 | 63VBJ99DEPIGMENTOR N.E.C. | New England District Office (NWE-DO) | |
| 4/19/2012 | 63VBY99DEPIGMENTOR N.E.C. | New England District Office (NWE-DO) | |
| 4/19/2012 | 53LG99OTHER SKIN CARE PREPARATIONS, N.E.C. | New England District Office (NWE-DO) | |
| 4/19/2012 | 63VBJ99DEPIGMENTOR N.E.C. | New England District Office (NWE-DO) | |
| 4/19/2012 | 62WBJ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | New England District Office (NWE-DO) | |
| 4/19/2012 | 65LBJ15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) | New England District Office (NWE-DO) | |
| 4/19/2012 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | New England District Office (NWE-DO) | |
| 4/19/2012 | 63VBU99DEPIGMENTOR N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 4/19/2012 | 63VDL02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 4/19/2012 | 62GBU99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 4/19/2012 | 63VBU99DEPIGMENTOR N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 8/10/2010 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 8/10/2010 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 1/24/2007 | 73BWINEEDLE, ACUPUNCTURE | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 63ICL03TRICHLOROACETIC ACID (CAUSTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 66PDJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 63VDY99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 63VDY99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 63VDY99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 63VDL99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 63VBL99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 63VDJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 62FDL99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 62FDL99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2007 | 62FDL99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Stalder Laboratiories's FDA import refusal history?
Stalder Laboratiories (FEI: 3007094293) has 30 FDA import refusal record(s) in our database, spanning from 1/24/2007 to 8/1/2013.
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. Stalder Laboratiories's FEI number is 3007094293.
What types of violations has Stalder Laboratiories received?
Stalder Laboratiories has been cited for 7 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 Stalder Laboratiories come from?
All FDA import refusal data for Stalder Laboratiories 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.