FDA Inspection
ALLcare Fertility CenterALLcare Fertility Center – FDA Inspection, Nov 6, 2024
Record Details
This FDA Inspection record concerns ALLcare Fertility Center, with an inspection on November 6, 2024, issued by the New York District Office, covering biologics.
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ID · f53da42e-30b6-4d35-b131-a7c5e0768f43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1253847
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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