FDA Inspection
Xytex LaboratoriesXytex Laboratories – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Xytex Laboratories, with an inspection on December 21, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · e0bc30f9-8ffa-4c0c-ab9a-2deadfac679e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078096
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Xytex Laboratories
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 5, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Xytex Laboratories
- FDA Inspection 1248987 - 2024-09-05
- FDA Inspection 1177571 - 2022-08-05
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