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FDA Inspection
•Brown Fertility Associates, PA•September 25, 2024

Brown Fertility Associates, PA – FDA Inspection, Sep 25, 2024

Record Details

This FDA Inspection record concerns Brown Fertility Associates, PA, with an inspection on September 25, 2024, issued by the Florida District Office, covering biologics.

Company
Brown Fertility Associates, PA
Inspection Date
September 25, 2024
Product Type
Biologics
Office
Florida District Office
Person
  • Barbara T. Carmichael (FDA Associated Person)
View Company Profile

ID · f042f9cf-c395-448a-aae3-229897c3a199

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1250057
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

2
  1. 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
  2. 21 CFR 1271.90(c)Eligibility not required--warning labels

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Brown Fertility Associates, PA

5
DateClassificationOfficeProject area
October 15, 2025NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
January 9, 2020VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
November 9, 2017VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 29, 2015VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
January 28, 2013VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Brown Fertility Associates, PA
  • FDA Inspection 1288928 - 2025-10-15
  • FDA Inspection 1114658 - 2020-01-09
  • FDA Inspection 1031252 - 2017-11-09
  • FDA Inspection 947767 - 2015-10-29
  • FDA Inspection 814880 - 2013-01-28

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