Home / CFR sections / 21 CFR 606.100(b)

21 CFR 606.100(b) citations

Written SOPs available for use by personnel

FDA investigators cited 21 CFR 606.100(b) 1,098 times at 725 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
202634
202543
202423
202313
202224
20218
20209
201936
201830
201755

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 StatesWritten standard operating procedures including all steps to be followed in the processing, storage and distribution of blood and blood components for allogeneic transfusion were not always established, maintained and…
Jul 20, 2026HCSC-Blood CenterUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for further manufacturing purposes were not always followed.
Jul 17, 2026New York Blood Center, Inc.United StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion were not always followed.
Jul 17, 2026New York Blood Center, Inc.United StatesFailure to make available written procedures for use by personnel in the areas where the procedures are performed.
Jul 16, 2026UC Health Poudre Valley HospitalUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion were not always established, maintained and followed.
Jul 14, 2026Sullivan Memorial Blood CenterUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion and further manufacturing purposes were not always followed.
Jun 23, 2026New York Blood Center, Inc.United StatesWritten standard operating procedures including all steps to be followed in the collection, processing, compatibility testing, storage and distribution of blood and blood components for further manufacturing purposes…
Jun 9, 2026Join Parachute, LLCUnited StatesWritten standard operating procedures including all steps to be followed in the distribution of blood and blood components for further manufacturing purposes were not always followed.
May 6, 2026The American National Red CrossUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion and autologous transfusion were not always established, maintained and…
May 1, 2026Long Island Jewish Medical CenterUnited StatesWritten standard operating procedures including all steps to be followed in the storage and distribution of blood and blood components for allogeneic transfusion, autologous transfusion and further manufacturing…
May 1, 2026Zablocki, Clement J., Veterans Affairs Medical CenterUnited StatesWritten standard operating procedures including all steps to be followed in the storage of blood and blood components for allogeneic transfusion were not always followed.
Apr 23, 2026New York Blood Center EnterprisesUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion were not always followed.
Apr 14, 2026Biomat USA IncUnited StatesWritten standard operating procedures including all steps to be followed in the collection and storage of blood and blood components for were not always followed.
Apr 13, 2026Scott & White Memorial HospitalUnited StatesWritten standard operating procedures including all steps to be followed in the distribution of blood and blood components for allogeneic transfusion were not always established and maintained.
Mar 11, 2026North Shore University Hospital Northwell HealthUnited StatesWritten standard operating procedures including all steps to be followed in the compatibility testing and distribution of blood and blood components for allogeneic transfusion were not always followed.
Mar 6, 2026Guam Memorial Hosp AuthorityUnited StatesWritten standard operating procedures including all steps to be followed in the collection and distribution of blood and blood components for allogeneic transfusion were not always followed.
Mar 3, 2026Kedplasma LLCUnited StatesWritten standard operating procedures including all steps to be followed in the storage of blood and blood components for further manufacturing purposes were not always maintained and followed.
Feb 23, 2026VitalantUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for further manufacturing purposes were not always followed.
Feb 19, 2026New York Blood Center EnterprisesUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion were not always followed.
Feb 11, 2026New York Blood Center EnterprisesUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion were not always followed.
Feb 4, 2026Biomat USA IncUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for further manufacturing purposes were not always followed.
Feb 2, 2026B Positive National Blood Services - Wyoming, LLC.United StatesWritten standard operating procedures including all steps to be followed in the collection, processing, storage and distribution of blood and blood components for further manufacturing purposes were not always…
Jan 28, 2026Biomat USA IncUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for further manufacturing purposes were not always followed.
Jan 22, 2026Olgam Life LLCUnited StatesWritten standard operating procedures including all steps to be followed in the collection of blood and blood components for further manufacturing purposes were not always followed.
Jan 12, 2026New York Blood Center EnterprisesUnited StatesFailure to make available written procedures for use by personnel in the areas where the procedures are performed.

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