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21 CFR 606.100(c) citations

Thorough investigations

FDA investigators cited 21 CFR 606.100(c) 417 times at 313 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Apr 14, 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
20264
202521
20245
20237
202210
20211
20202
201914
20187
201725

Recent citations

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

Inspection endedFacilityCountryObservation
Apr 14, 2026Biomat USA IncUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Jan 13, 2026The Blood Connection - LexingtonUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Dec 5, 2025BioLife Plasma Services LPUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Nov 6, 2025Biomat USA IncUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Aug 29, 2025Central California Blood CenterUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Aug 29, 2025Creative Testing SolutionsUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Aug 8, 2025VA Boston Healthcare SystemUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Jul 30, 2025Reading HospitalUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Jul 1, 2025Harper University HospitalUnited StatesFailure to perform a thorough investigation of an unexplained discrepancy.
Jun 12, 2025VitalantUnited StatesAll records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.
Jun 12, 2025VitalantUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.
May 27, 2025Blood Connection, Inc. (The)United StatesFailure to perform a thorough investigation of an unexplained discrepancy.
May 9, 2025Ascension Saint John Medical CenterUnited StatesAll records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.
May 9, 2025Ascension Saint John Medical CenterUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.
May 1, 2025Department Of The Army Blanchfield Army Community HospitalUnited StatesFailure to perform a thorough investigation of an unexplained discrepancy.
Apr 24, 2025Baptist Health Deaconess Madisonville IncUnited StatesFailure to perform a thorough investigation of an unexplained discrepancy.
Apr 14, 2025Lifesouth Community Blood Centers - Montgomery RegionUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Apr 1, 2025University Medical Center Of Southern NevadaUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.
Mar 27, 2025Department Of Defense - Air Force, 99Th Medical GroupUnited StatesFailure to perform a thorough investigation of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.
Mar 26, 2025Lifesouth Community Blood Centers Inc. - East Alabama RegionUnited StatesFailure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.
Feb 28, 2025Ioannis Lougaris VA Medical Center Laboratory Service (113) Blood BankUnited StatesFailure to make a record of the conclusions and follow-up of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.
Feb 7, 2025VitalantUnited StatesAll records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.
Feb 7, 2025VitalantUnited StatesFailure to perform a thorough investigation of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.
Jan 31, 2025Suncoast Communities Blood Bank, Inc.United StatesFailure to perform a thorough investigation of an unexplained discrepancy.
Jan 9, 2025Biomat USA, Inc.United StatesFailure to perform a thorough investigation of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.

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