FDA Inspection
APEX Biologix, LLCAPEX Biologix, LLC – FDA Inspection, Sep 1, 2022
Record Details
This FDA Inspection record concerns APEX Biologix, LLC, with an inspection on September 1, 2022, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- APEX Biologix, LLC
- Inspection Date
- September 1, 2022
- Product Type
- Biologics
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ID · ae39522a-aef7-41b4-81b4-793d842031f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1178720
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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