Vivant Skin Care, LLC
Form 483 issued December 5, 2024 · Miami Lakes, Florida
- Inspection
- Dec 2 – Dec 5, 2024
- Investigators
- Joanne E. King· Mabany Lizardi
- Observations
- 5
- Pages
- 5
- FEI number
- 3009868709
In short: On December 5, 2024, FDA issued a Form 483 with 5 observations to Vivant Skin Care, LLC in Miami Lakes, Florida (FEI 3009868709) after an inspection that ran Dec 2 – Dec 5, 2024. The investigators were Joanne E. King and Mabany Lizardi. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Sampling and testing plans for drug products are not described in written procedures which include the…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmVivant Skin Care, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vivant Skin Care, LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Vivant Skin Care, LLC?
Joanne E. King and Mabany Lizardi are named on this Form 483, for the inspection of Dec 2 – Dec 5, 2024. Each investigator has a profile showing what they cite most.
When was Vivant Skin Care, LLC inspected by FDA?
The inspection ran Dec 2 – Dec 5, 2024, and the Form 483 is dated December 5, 2024.
How do I get the full Form 483 for Vivant Skin Care, LLC?
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.