Kinetics Derma Beauty, LLC
Form 483 issued May 3, 2024 · Sugar Land, Texas
- Inspection
- Apr 29 – May 3, 2024
- Investigator
- Timothy H. Vo
- Observations
- 7
- Pages
- 4
- FEI number
- 3015841037
In short: On May 3, 2024, FDA issued a Form 483 with 7 observations to Kinetics Derma Beauty, LLC in Sugar Land, Texas (FEI 3015841037) after an inspection that ran Apr 29 – May 3, 2024. The investigator was Timothy H. Vo. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
The quality control unit lacks authority to review production records to assure that no errors have…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Timothy H. Vo
9 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmKinetics Derma Beauty, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kinetics Derma Beauty, LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. 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 Kinetics Derma Beauty, LLC?
Timothy H. Vo is named on this Form 483, for the inspection of Apr 29 – May 3, 2024. Each investigator has a profile showing what they cite most.
When was Kinetics Derma Beauty, LLC inspected by FDA?
The inspection ran Apr 29 – May 3, 2024, and the Form 483 is dated May 3, 2024.
How do I get the full Form 483 for Kinetics Derma Beauty, 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.