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21 CFR 1271.75(a)(1) citations

Risk factors, clinical evidence

FDA investigators cited 21 CFR 1271.75(a)(1) 337 times at 253 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jun 18, 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
20267
202518
202424
202339
202235
202116
202022
201935
201833
201715

Recent citations

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

Inspection endedFacilityCountryObservation
Jun 18, 2026Palo Alto Medical Foundation Reproductive Endocrinology And InfertilityUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Apr 22, 2026New Infertility Center Of St LouisUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Apr 14, 2026Southwest Fertility CenterUnited StatesDonors were not screened by a review of relevant medical records for of communicable disease agents and diseases.
Mar 25, 2026Vaughn, Silverberg, & Associates, LLPUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Feb 26, 2026University Of Cincinnati Center For Reproductive HealthUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Feb 5, 2026NexCell Scientific IncUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Oct 21, 2025Aligneage Fertility Laboratory, LLCUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Sep 9, 2025Boston IVF Fertility Services At The Women's Hospital, LLCUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Jul 31, 2025CARE For The Bay AreaUnited StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
Jun 30, 2025Arizona Reproductive Medicine SpecialistsUnited StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
May 16, 2025Central Coast Multispecialty Medical Group, Inc.United StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
May 14, 2025Green Valley Fertility PartnersUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
May 1, 2025Advanced Fertility Associates Medical Group, Inc.United StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
Apr 25, 2025The Advanced IVF Institute: Charles E. Miller, M.D. & AssociatesUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Apr 24, 2025Fort Worth Fertility P.A.United StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
Apr 2, 2025New Directions Fertility CenterUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Mar 12, 2025Pacific Reproductive Center IncUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Mar 5, 2025Richard Joseph Schmidt, MD, Inc.United StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
Feb 24, 2025Incinta Fertility Center, LLCUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Feb 5, 2025InVia Fertility Specialists, PLLCUnited StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
Jan 13, 2025Pacific Reproductive Center, Inc.United StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Dec 17, 2024Innovative Fertility CenterUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Dec 3, 2024California Fertility Partners, A Medical Group, Professional CorporationsUnited StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
Nov 25, 2024Midwest Fertility SpecialistsUnited StatesDonors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
Oct 7, 2024Fertility Care Of Orange County, A Medical CorporationUnited StatesDonors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.

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