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FDA Inspection
•Ionetix Corporation•September 22, 2023

Ionetix Corporation – FDA Inspection, Sep 22, 2023

Record Details

This FDA Inspection record concerns Ionetix Corporation, with an inspection on September 22, 2023, issued by the New Orleans District Office.

Company
Ionetix Corporation
Inspection Date
September 22, 2023
Office
New Orleans District Office
People
  • Gretchen M. Laws (Issuing Officer)
  • Joanne E. King (FDA Associated Person)
View Company Profile

ID · 9aac60c5-c7ec-47ae-8243-e16afcf83320

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1218365
FDA center
Human Drugs
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 212.10Personnel not qualified
  2. 21 CFR 212.30(b)Equipment procedures
  3. 21 CFR 212.40(d)Contamination, mix-ups and deterioration

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ionetix Corporation

1
DateClassificationOfficeProject area
February 6, 2025Not classifiedNew Orleans District Office
Other documents for Ionetix Corporation
  • FDA Inspection 1275918 - 2025-02-06

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