Cosmetic Essence, LLC dba Voyant Beauty
Form 483 issued March 28, 2025 · Roanoke, Virginia
- Inspection
- Mar 25 – Mar 28, 2025
- Investigator
- Olumide A. Akinyemi
- Observations
- 9
- Pages
- 6
- FEI number
- 1117550
In short: On March 28, 2025, FDA issued a Form 483 with 9 observations to Cosmetic Essence, LLC dba Voyant Beauty in Roanoke, Virginia (FEI 1117550) after an inspection that ran Mar 25 – Mar 28, 2025. The investigator was Olumide A. Akinyemi. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
- 03
Written records are not made of…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Olumide A. Akinyemi
5 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmCosmetic Essence, LLC dba Voyant Beauty history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosmetic Essence, LLC dba Voyant Beauty?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Cosmetic Essence, LLC dba Voyant Beauty?
Olumide A. Akinyemi is named on this Form 483, for the inspection of Mar 25 – Mar 28, 2025. Each investigator has a profile showing what they cite most.
When was Cosmetic Essence, LLC dba Voyant Beauty inspected by FDA?
The inspection ran Mar 25 – Mar 28, 2025, and the Form 483 is dated March 28, 2025.
How do I get the full Form 483 for Cosmetic Essence, LLC dba Voyant Beauty?
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.