Vee Pak, LLC dba Voyant Beauty

Form 483 issued December 10, 2024 · Hodgkins, Illinois

Inspection
Dec 9 – Dec 10, 2024
Investigator
Jean Claude Garay
Observations
2
Pages
4
FEI number
3005163279

In short: On December 10, 2024, FDA issued a Form 483 with 2 observations to Vee Pak, LLC dba Voyant Beauty in Hodgkins, Illinois (FEI 3005163279) after an inspection that ran Dec 9 – Dec 10, 2024. The investigator was Jean Claude Garay. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

Quality system and laboratory controls account for 2 of 2 observations.

Quality system1
Laboratory controls1

Most cited: 21 CFR 211.192 (1×) · 211.160(b) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Written records of investigations into unexplained discrepancies and the failure of a batch or any of…

  2. 02

    Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

Questions about this 483

What did FDA find at Vee Pak, LLC dba Voyant Beauty?

FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.

Who inspected Vee Pak, LLC dba Voyant Beauty?

Jean Claude Garay is named on this Form 483, for the inspection of Dec 9 – Dec 10, 2024. Each investigator has a profile showing what they cite most.

When was Vee Pak, LLC dba Voyant Beauty inspected by FDA?

The inspection ran Dec 9 – Dec 10, 2024, and the Form 483 is dated December 10, 2024.

How do I get the full Form 483 for Vee Pak, LLC dba Voyant Beauty?

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