Mary Kay Inc.
Form 483 issued October 27, 2023 · Lewisville, Texas
- Investigator
- Kevin T. Nguyen
- Observations
- 1
- Pages
- 2
- FEI number
- 3014970187
In short: On October 27, 2023, FDA issued a Form 483 with 1 observation to Mary Kay Inc. in Lewisville, Texas (FEI 3014970187). The investigator was Kevin T. Nguyen. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(b)(5) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
This inspection in context
Kevin T. Nguyen
5 documents · 2022–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Texas.
The firmMary Kay Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)(5)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mary Kay Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Mary Kay Inc.?
Kevin T. Nguyen is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Mary Kay Inc. inspected by FDA?
This Form 483 is dated October 27, 2023.
How do I get the full Form 483 for Mary Kay 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.