Evonik Active Oxygens, LLC
Form 483 issued November 6, 2024 · Pasadena, Texas
- Inspection
- Nov 4 – Nov 6, 2024
- Investigator
- Timothy H. Vo
- Observations
- 2
- Pages
- 3
- FEI number
- 1618369
In short: On November 6, 2024, FDA issued a Form 483 with 2 observations to Evonik Active Oxygens, LLC in Pasadena, Texas (FEI 1618369) after an inspection that ran Nov 4 – Nov 6, 2024. The investigator was Timothy H. Vo. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to exercise sufficient controls over computerized systems to prevent unauthorized access…
- 02
Failure to document and investigate any…
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 firmEvonik Active Oxygens, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Evonik Active Oxygens, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. 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 Evonik Active Oxygens, LLC?
Timothy H. Vo is named on this Form 483, for the inspection of Nov 4 – Nov 6, 2024. Each investigator has a profile showing what they cite most.
When was Evonik Active Oxygens, LLC inspected by FDA?
The inspection ran Nov 4 – Nov 6, 2024, and the Form 483 is dated November 6, 2024.
How do I get the full Form 483 for Evonik Active Oxygens, LLC?
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