Sterigenics US, LLC
Form 483 issued August 23, 2022 · Fort Worth, Texas
- Inspection
- Aug 17 – Aug 23, 2022
- Investigators
- Brittny C. Cargo· Patty P. Kaewussdangkul· Timothy H. Vo
- Observations
- 1
- Pages
- 4
- FEI number
- 3001236277
In short: On August 23, 2022, FDA issued a Form 483 with 1 observation to Sterigenics US, LLC in Fort Worth, Texas (FEI 3001236277) after an inspection that ran Aug 17 – Aug 23, 2022. The investigators were Brittny C. Cargo, Patty P. Kaewussdangkul and Timothy H. Vo. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written test procedures are…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
The firmSterigenics US, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sterigenics US, LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sterigenics US, LLC?
Brittny C. Cargo, Patty P. Kaewussdangkul and Timothy H. Vo are named on this Form 483, for the inspection of Aug 17 – Aug 23, 2022. Each investigator has a profile showing what they cite most.
When was Sterigenics US, LLC inspected by FDA?
The inspection ran Aug 17 – Aug 23, 2022, and the Form 483 is dated August 23, 2022.
How do I get the full Form 483 for Sterigenics US, LLC?
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