FDA Inspection
Pelex Medical of TexasPelex Medical of Texas – FDA Inspection, Jul 28, 2023
Record Details
This FDA Inspection record concerns Pelex Medical of Texas, with an inspection on July 28, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 031498cd-d529-4e9b-a0e4-5a0eb2121399
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210975
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.85(a)Infection with communicable disease agents
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