FDA Inspection
Cryomate Indiana LLCCryomate Indiana LLC – FDA Inspection, Jun 7, 2024
Record Details
This FDA Inspection record concerns Cryomate Indiana LLC, with an inspection on June 7, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ecfa94c5-29f0-42e1-b485-f4b8f6305fe3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1240542
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.55(d)(1)Documentation maintained (general)
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(e)Abbreviated procedure
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