FDA Inspection
Texas Children's Hospital North AustinTexas Children's Hospital North Austin – FDA Inspection, Sep 17, 2025
Record Details
This FDA Inspection record concerns Texas Children's Hospital North Austin, with an inspection on September 17, 2025, issued by the Dallas District Office, covering biologics.
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ID · 925dba59-366b-41a6-8c88-fef20163b46d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1282688
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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