Home / CFR sections / 21 CFR 606.160(a)(1)

21 CFR 606.160(a)(1) citations

Person performing, test results, interpretation

FDA investigators cited 21 CFR 606.160(a)(1) 533 times at 351 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 7, 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
20266
202520
202416
20236
20226
20212
20203
201920
201812
201724

Recent citations

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

Inspection endedFacilityCountryObservation
Aug 7, 2026Munson Medical CenterUnited StatesRecords fail to identify the person performing the work so as to provide a complete history of the work performed.
Jul 17, 2026New York Blood Center, Inc.United StatesRecords fail to identify the person performing the work and be as detailed as necessary so as to provide a complete history of the work performed.
Mar 11, 2026North Shore University Hospital Northwell HealthUnited StatesRecords fail to identify the person performing the work so as to provide a complete history of the work performed.
Feb 4, 2026Biomat USA IncUnited StatesRecords fail to show test results so as to provide a complete history of the work performed.
Jan 12, 2026Biomat USA IncUnited StatesRecords are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.
Dec 5, 2025New York Blood Center EnterprisesUnited StatesRecords fail to identify the person performing the work and be as detailed as necessary so as to provide a complete history of the work performed.
Sep 12, 2025Pasadena Hospital Association, Ltd.United StatesRecords fail to identify the person performing the work, include dates of the various entries and be as detailed as necessary so as to provide a complete history of the work performed.
Sep 10, 2025LifeSouth Community Blood Centers IncUnited StatesRecords are not concurrently maintained with the performance of each significant step in the collection, processing, storage and distribution of each unit of blood and blood components so that all steps can be clearly…
Aug 26, 2025VA Black Hills Health Care System - Fort MeadeUnited StatesRecords are not concurrently maintained with the performance of each significant step in the storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
Aug 6, 2025Emerson Health HospitalUnited StatesRecords are not concurrently maintained with the performance of each significant step in the processing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
Aug 1, 2025Rhode Island Blood Center, A Division Of New York Blood Center, Inc.United StatesRecords fail to identify the person performing the work, include dates of the various entries and be as detailed as necessary so as to provide a complete history of the work performed.
Jun 12, 2025VitalantUnited StatesRecords are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.
May 8, 2025William S. Middleton Memorial Veteran's HospitalUnited StatesRecords are not concurrently maintained with the performance of each significant step in the storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
May 1, 2025Department Of The Army Blanchfield Army Community HospitalUnited StatesRecords are not concurrently maintained with the performance of each significant step in the storage of each unit of blood and blood components so that all steps can be clearly traced.
Apr 23, 2025Western Kentucky Regional Blood CtrUnited StatesRecords are not concurrently maintained with the performance of each significant step in the processing and storage of each unit of blood and blood components so that all steps can be clearly traced.
Apr 15, 2025Department Of Defense - Navy (U.S. Naval Hospital Naples)ItalyRecords fail to be as detailed as necessary so as to provide a complete history of the work performed.
Mar 20, 2025Children's Hospital And Research Center At OaklandUnited StatesRecords are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.
Feb 13, 2025Memorial Hospital For Cancer & Allied DiseasesUnited StatesRecords are not concurrently maintained with the performance of each significant step in the storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
Feb 10, 2025A Plus Phlebotomy ServicesUnited StatesRecords are not concurrently maintained with the performance of each significant step in the collection, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
Feb 7, 2025VitalantUnited StatesRecords are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.
Jan 9, 2025Biomat USA, Inc.United StatesRecords are not concurrently maintained with the performance of each significant step in the collection of each unit of blood and blood components so that all steps can be clearly traced.
Dec 17, 2024Jackson Memorial Hospital Transfusion Medicine ServicesUnited StatesRecords are not concurrently maintained with the performance of each significant step in the storage of each unit of blood and blood components so that all steps can be clearly traced.
Nov 25, 2024District Hospital Partners LPUnited StatesRecords are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.
Nov 19, 2024Morristown Medical Center Blood BankUnited StatesRecords fail to identify the person performing the work, include dates of the various entries and be as detailed as necessary so as to provide a complete history of the work performed.
Oct 31, 2024UCH-MHSUnited StatesRecords are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.

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