L'Oreal USA, Inc.
Form 483 issued September 30, 2022 · FLORENCE, Kentucky
- Investigator
- Kevin P. Regan
- Observations
- 4
- Pages
- 4
- FEI number
- 3003763470
In short: On September 30, 2022, FDA issued a Form 483 with 4 observations to L'Oreal USA, Inc. in FLORENCE, Kentucky (FEI 3003763470). The investigator was Kevin P. Regan. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
Deviations from written sampling plans and laboratory mechanisms are…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
This inspection in context
Kevin P. Regan
7 documents · 2021–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Minnesota.
The firmL'Oreal USA, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at L'Oreal USA, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected L'Oreal USA, Inc.?
Kevin P. Regan is named on this Form 483. Each investigator has a profile showing what they cite most.
When was L'Oreal USA, Inc. inspected by FDA?
This Form 483 is dated September 30, 2022.
How do I get the full Form 483 for L'Oreal USA, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.