Galbraith Laboratories Inc
Form 483 issued March 2, 2022 · Knoxville, Tennessee
- Inspection
- Feb 28 – Mar 2, 2022
- Investigators
- Timothy H. Vo· Veronica Fuentes
- Observations
- 3
- Pages
- 3
- FEI number
- 1000112629
In short: On March 2, 2022, FDA issued a Form 483 with 3 observations to Galbraith Laboratories Inc in Knoxville, Tennessee (FEI 1000112629) after an inspection that ran Feb 28 – Mar 2, 2022. The investigators were Timothy H. Vo and Veronica Fuentes. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.68(a) (1×) · 211.22(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Routine inspection and checking of electronic equipment is not performed according to a written program designed…
- 02
The quality control unit lacks authority to fully investigate…
- 03
Ail observation concerning (b) (4) . was rei noved based on…
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 firmGalbraith Laboratories Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Galbraith Laboratories Inc?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment 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 Galbraith Laboratories Inc?
Timothy H. Vo and Veronica Fuentes are named on this Form 483, for the inspection of Feb 28 – Mar 2, 2022. Each investigator has a profile showing what they cite most.
When was Galbraith Laboratories Inc inspected by FDA?
The inspection ran Feb 28 – Mar 2, 2022, and the Form 483 is dated March 2, 2022.
How do I get the full Form 483 for Galbraith Laboratories Inc?
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