Drug factory · FDA FEI 1000122130
L'oreal USA Products, Inc.
100 COMMERCE DR, Somerset, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 15, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Avobenzone, Homosalate, Octisalate, Octocrylene | Makes it | L'Oreal USA Products Inc | 49967-329 |
| Homosalate, Octocrylene, Oxybenzone, Octisalate, Avobenzone and Drometrizole Tri | Makes it and packages it | L'Oreal USA Products Inc | 49967-083, 49967-704 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 15, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 31, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 23, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 4, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 21, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 15, 2024 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Dec 4, 2012 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Registered with FDA for: analysis; manufacture; pack.