Home / CFR sections / 21 CFR 1271.50(a)

21 CFR 1271.50(a) citations

Responsible person to determine, document

FDA investigators cited 21 CFR 1271.50(a) 338 times at 231 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 13, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal yearCitations
20265
202525
202430
202330
202217
202115
202010
201919
201822
20177

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection endedFacilityCountryObservation
Aug 13, 2026CCRM Seattle LLCUnited StatesThe eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
Apr 22, 2026New Infertility Center Of St LouisUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Apr 1, 2026Repromed Fertility CenterUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Feb 5, 2026NexCell Scientific IncUnited StatesThe eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
Dec 16, 2025Bello Bio LLCUnited StatesThe eligibility of an HCT/P donor was not documented by a responsible person, based on results of donor screening and donor testing.
Jul 8, 2025Southern California Reproductive Center Medical Group PCUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Jun 13, 2025Conceive Fertility CenterUnited StatesThe eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
May 14, 2025Reproductive Care CenterUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Apr 30, 2025MFC Lab, Inc.United StatesThe eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
Apr 24, 2025Fort Worth Fertility P.A.United StatesThe eligibility of an HCT/P donor was not determined by a responsible person, based on results of donor screening and donor testing.
Apr 9, 2025Kofinas Fertility GroupUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Apr 9, 2025Kofinas Fertility GroupUnited StatesThe eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
Apr 2, 2025New Directions Fertility CenterUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Mar 26, 2025The Sperm And Embryo Bank Of New Jersey, Inc.United StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Mar 14, 2025Fertility Center Of Southern CaliforniaUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Mar 12, 2025Lin, James P MD Inc. D.B.A. Reproductive Fertility CenterUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Mar 12, 2025Pacific Reproductive Center IncUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Feb 26, 2025Billings Clinic Fertility SpecialistsUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Feb 26, 2025Billings Clinic Fertility SpecialistsUnited StatesThe eligibility of an HCT/P donor was not by a responsible person, based on results of donor screening and donor testing.
Jan 13, 2025Pacific Reproductive Center, Inc.United StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Dec 20, 2024Columbia University Fertility CenterUnited StatesThe eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
Dec 20, 2024Columbia University Fertility CenterUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Dec 20, 2024Neway Medical, P.C.United StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Dec 9, 2024GLOBAL FERTILITY & GENETICSUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Nov 22, 2024Chelsea Fertility NYCUnited StatesHCT/P donors were not determined to be eligible based on the results of donor screening and testing.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.