FDA Inspection
Steri-Tek, LLCFDA Inspection 1234113 - Steri-Tek, LLC - March 26, 2024
Record Details
This FDA Inspection record concerns Steri-Tek, LLC, with an inspection on March 26, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d921006f-0b18-4aca-a6e4-c0e79c8123b2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234113
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Steri-Tek, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Steri-Tek, LLC
- FDA Inspection 1220467 - 2023-09-26
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