Gala Industrial, S.A.
⚠️ Moderate Risk
FEI: 3003459057 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3003459057
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle San Fco. De Asis 73 Alma Rosa, , Santo Domingo, , Dominican Republic
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).
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Juan District Office (SJN-DO) | |
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Juan District Office (SJN-DO) | |
| 10/20/2005 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | San Juan District Office (SJN-DO) |
| 10/20/2005 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Juan District Office (SJN-DO) | |
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Juan District Office (SJN-DO) | |
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Juan District Office (SJN-DO) | |
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Gala Industrial, S.A.'s FDA import refusal history?
Gala Industrial, S.A. (FEI: 3003459057) has 8 FDA import refusal record(s) in our database, spanning from 10/20/2005 to 10/20/2005.
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. Gala Industrial, S.A.'s FEI number is 3003459057.
What types of violations has Gala Industrial, S.A. received?
Gala Industrial, S.A. 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 Gala Industrial, S.A. come from?
All FDA import refusal data for Gala Industrial, S.A. 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.