Colorlab Cosmetics, Inc.
Form 483 issued January 6, 2022 · Williston, Vermont
- Inspection
- Dec 14, 2021 – Jan 6, 2022
- Investigator
- Edmund F. Mrak
- Observations
- 2
- Pages
- 13
- FEI number
- 3005000375
In short: On January 6, 2022, FDA issued a Form 483 with 2 observations to Colorlab Cosmetics, Inc. in Williston, Vermont (FEI 3005000375) after an inspection that ran Dec 14, 2021 – Jan 6, 2022. The investigator was Edmund F. Mrak. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmColorlab Cosmetics, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Colorlab Cosmetics, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Colorlab Cosmetics, Inc.?
Edmund F. Mrak is named on this Form 483, for the inspection of Dec 14, 2021 – Jan 6, 2022. Each investigator has a profile showing what they cite most.
When was Colorlab Cosmetics, Inc. inspected by FDA?
The inspection ran Dec 14, 2021 – Jan 6, 2022, and the Form 483 is dated January 6, 2022.
How do I get the full Form 483 for Colorlab Cosmetics, 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.