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FDA Inspection
•South Florida Institute For Reproductive Medicine, P.A.•August 3, 2018

South Florida Institute For Reproductive Medicine, P.A. – FDA Inspection, Aug 3, 2018

Record Details

This FDA Inspection record concerns South Florida Institute For Reproductive Medicine, P.A., with an inspection on August 3, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
South Florida Institute For Reproductive Medicine, P.A.
Inspection Date
August 3, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Lura D. Kelly (Issuing Officer)
  • Shavon L. Square (Company Rep)
View Company Profile

ID · eb85de58-683e-48a4-9aa9-c0fabe8d7d91

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1062748
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

5
  1. 21 CFR 1271.55(a)(3)Summary--records used to make determination
  2. 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
  3. 21 CFR 1271.55(d)(2)Accurate, indelible, legible
  4. 21 CFR 1271.47(a)Procedures for all other requirements
  5. 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary

Full citation text and observation details available on the Dashboard.

Other FDA inspections of South Florida Institute For Reproductive Medicine, P.A.

3
DateClassificationOfficeProject area
January 22, 2026NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
October 19, 2022NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
September 3, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for South Florida Institute For Reproductive Medicine, P.A.
  • FDA Inspection 1300034 - 2026-01-22
  • FDA Inspection 1182041 - 2022-10-19
  • FDA Inspection 846791 - 2013-09-03

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