Gala SRL
⚠️ Moderate Risk
FEI: 3003746574 • Santo Domingo Este, Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3003746574
Location
Santo Domingo Este, Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle Proyecto No. 1, , Santo Domingo Este, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 4/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 4/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 8/8/2013 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 2/23/2010 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | San Juan District Office (SJN-DO) | |
| 2/23/2010 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | San Juan District Office (SJN-DO) | |
| 5/6/2005 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 5/6/2005 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 5/6/2005 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 5/6/2005 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Gala SRL's FDA import refusal history?
Gala SRL (FEI: 3003746574) has 10 FDA import refusal record(s) in our database, spanning from 5/6/2005 to 4/29/2020.
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 SRL's FEI number is 3003746574.
What types of violations has Gala SRL received?
Gala SRL has been cited for 5 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 SRL come from?
All FDA import refusal data for Gala SRL 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.