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21 CFR 1271.47(a) citations

Testing, screening, donor eligibility procedures

FDA investigators cited 21 CFR 1271.47(a) 537 times at 347 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Apr 22, 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
202527
202434
202328
202231
202118
202018
201937
201841
201710

Recent citations

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

Inspection endedFacilityCountryObservation
Apr 22, 2026New Infertility Center Of St LouisUnited StatesProcedures were not designed to ensure compliance with the donor eligibility requirements.
Feb 26, 2026University Of Cincinnati Center For Reproductive HealthUnited StatesYou did not establish and maintain procedures that address the accompanying records after the donor eligibility determination is complete of HCT/Ps.
Feb 5, 2026NexCell Scientific IncUnited StatesProcedures were not designed to ensure compliance with the donor eligibility requirements.
Dec 16, 2025Bello Bio LLCUnited StatesProcedures were not designed to ensure compliance with the donor eligibility requirements.
Oct 21, 2025Aligneage Fertility Laboratory, LLCUnited StatesYou did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
Sep 15, 2025Alabama Center For Reproductive MedicineUnited StatesYou did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
Sep 9, 2025Boston IVF Fertility Services At The Women's Hospital, LLCUnited StatesYou did not establish and maintain procedures for screening of HCT/P donors.
Aug 19, 2025NCFMC, A Medical CorporationUnited StatesProcedures were not designed to ensure compliance with the donor eligibility requirements.
Jul 16, 2025Tulsa Fertility Center, P.C.United StatesYou did not establish and maintain procedures for of HCT/P donors.
Jun 13, 2025Conceive Fertility CenterUnited StatesYou did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors.
Jun 12, 2025California Fertility Clinics LLCUnited StatesProcedures were not designed to ensure compliance with the donor eligibility requirements.
May 16, 2025Central Coast Multispecialty Medical Group, Inc.United StatesProcedures were not designed to ensure compliance with the donor eligibility requirements.
May 1, 2025Advanced Fertility Associates Medical Group, Inc.United StatesYou did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
Apr 30, 2025MFC Lab, Inc.United StatesYou did not establish and maintain procedures for screening of HCT/P donors.
Apr 2, 2025New Directions Fertility CenterUnited StatesYou did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors.
Mar 26, 2025The Sperm And Embryo Bank Of New Jersey, Inc.United StatesProcedures were not designed to ensure compliance with the donor eligibility requirements.
Mar 12, 2025Pacific Reproductive Center IncUnited StatesYou did not establish and maintain procedures for screening of HCT/P donors.
Mar 5, 2025Richard Joseph Schmidt, MD, Inc.United StatesYou did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
Feb 24, 2025Incinta Fertility Center, LLCUnited StatesYou did not establish and maintain procedures for screening of HCT/P donors.
Feb 18, 2025Fangyinmeng MD Inc.United StatesYou did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
Feb 5, 2025InVia Fertility Specialists, PLLCUnited StatesYou did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors.
Jan 13, 2025Cryobank America LLCUnited StatesYou did not establish and maintain procedures that address the retention of records related to testing, screening, and determining of donor eligibility of HCT/Ps.
Jan 13, 2025Pacific Reproductive Center, Inc.United StatesYou did not establish and maintain procedures for screening of HCT/P donors.
Dec 20, 2024Neway Medical, P.C.United StatesProcedures were not designed to ensure compliance with the donor eligibility requirements.
Dec 20, 2024Neway Medical, P.C.United StatesYou did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.

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