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1247743

Marwan M. Shaykh, M.D. dba Assisted Fertility Program — FEI 3005033067

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 28, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Jacksonville, FL (United States)

Facility

Other inspections at this facility

  • 1112318 (NAI Wed Nov 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034786 (VAI Wed Nov 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 916043 (VAI Wed Feb 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 632922 (VAI Mon Dec 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222321 CFR 1271.47(b)Review and approval of procedures
1222921 CFR 1271.50(a)Determination based on screening and testing
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1228621 CFR 1271.80(b)Specimen collections not timely
1229021 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
1230121 CFR 1271.150(c)(1)(iii)Ensurane of compliance
1249421 CFR 1271.85(c)Reproductive cells or tissues