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1061558

Specialists in Reproductive Medicine & Surgery, P.A. — FEI 3003926777

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 9, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Fort Myers, FL (United States)

Facility

Other inspections at this facility

  • 1246307 (NAI Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167265 (VAI Fri Apr 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969003 (NAI Wed Feb 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 840450 (VAI Wed Jul 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 583184 (VAI Thu May 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1222921 CFR 1271.50(a)Determination based on screening and testing
1223921 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228021 CFR 1271.75(c)Reproductive cells/ tissues- general
1228621 CFR 1271.80(b)Specimen collections not timely
1249221 CFR 1271.85(a)Infection with communicable disease agents