Cosmetic Essence, LLC dba Voyant Beauty
Form 483 issued December 6, 2024 · Ridgefield, New Jersey
- Inspection
- Dec 4 – Dec 6, 2024
- Investigators
- Suchan Kim· Syeda N. Mahazabin
- Observations
- 2
- Pages
- 4
- FEI number
- 1000222321
In short: On December 6, 2024, FDA issued a Form 483 with 2 observations to Cosmetic Essence, LLC dba Voyant Beauty in Ridgefield, New Jersey (FEI 1000222321) after an inspection that ran Dec 4 – Dec 6, 2024. The investigators were Suchan Kim and Syeda N. Mahazabin. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.67(a) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Suchan Kim
7 documents · 2024–2026
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmCosmetic Essence, LLC dba Voyant Beauty history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
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 2 observations on this Form 483, mostly about facilities & equipment and quality system. 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 Cosmetic Essence, LLC dba Voyant Beauty?
Suchan Kim and Syeda N. Mahazabin are named on this Form 483, for the inspection of Dec 4 – Dec 6, 2024. Each investigator has a profile showing what they cite most.
When was Cosmetic Essence, LLC dba Voyant Beauty inspected by FDA?
The inspection ran Dec 4 – Dec 6, 2024, and the Form 483 is dated December 6, 2024.
How do I get the full Form 483 for Cosmetic Essence, LLC dba Voyant Beauty?
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