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FDA Inspection
•Rejuvenating Fertility Center PLLC•October 25, 2024

Rejuvenating Fertility Center PLLC – FDA Inspection, Oct 25, 2024

Record Details

This FDA Inspection record concerns Rejuvenating Fertility Center PLLC, with an inspection on October 25, 2024, issued by the New England District Office, covering biologics.

Company
Rejuvenating Fertility Center PLLC
Inspection Date
October 25, 2024
Product Type
Biologics
Office
New England District Office
Person
  • Anthony N. Onianwa (FDA Associated Person)
View Company Profile

ID · 839cbdd1-5b70-4e97-b598-7c2e10d9851b

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1252520
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 1271.80(b)Specimen collections not timely
  2. 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
  3. 21 CFR 1271.50(a)Determination based on screening and testing

Full citation text and observation details available on the Dashboard.

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