Galderma Laboratories, L.P.
⚠️ High Risk
FEI: 1000118068 • Dallas, TX • UNITED STATES
FEI Number
1000118068
Location
Dallas, TX
Country
UNITED STATESAddress
2001 Ross Ave Ste 1600, , Dallas, TX, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 6/10/2019 | 63VCO02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/1/2017 | 65QAK99RELAXANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2012 | 61HDK99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/20/2012 | 62SDJ02ADAPALENE (ANTI-SEBORRHEIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/1/2009 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2009 | 62SCY02ADAPALENE (ANTI-SEBORRHEIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 64LCL28FLUOCINONIDE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Galderma Laboratories, L.P.'s FDA import refusal history?
Galderma Laboratories, L.P. (FEI: 1000118068) has 8 FDA import refusal record(s) in our database, spanning from 7/16/2006 to 6/26/2025.
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. Galderma Laboratories, L.P.'s FEI number is 1000118068.
What types of violations has Galderma Laboratories, L.P. received?
Galderma Laboratories, L.P. has been cited for 3 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 Galderma Laboratories, L.P. come from?
All FDA import refusal data for Galderma Laboratories, L.P. 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.