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21 CFR 211.68(b) citations

Written record not kept of program and validation data

FDA investigators cited 21 CFR 211.68(b) 837 times at 666 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 24, 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
202659
202599
202463
202360
202260
202133
202039
201975
201875
201763

Recent citations

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

Inspection endedFacilityCountryObservation
Aug 24, 2026Noven Pharmaceuticals, Inc.United StatesInput to and output from records or data are not checked for accuracy.
Aug 24, 2026Noven Pharmaceuticals, Inc.United StatesFailure to maintain a backup file of data entered into the computer or related system.
Aug 12, 2026Steril-Gene Life Sciences Private LtdIndiaAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Jul 20, 2026Biochemical And Scientific Consultants CcSouth AfricaAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Jul 17, 2026I. Shay Cosmetics IncUnited StatesInput to and output from the computer and records or data are not checked for accuracy.
Jul 16, 2026Solvias USA, LLCUnited StatesInput to and output from the computer and records or data are not checked for accuracy.
Jul 2, 2026Biolink Life Sciences Carolinas Inc.United StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Jun 26, 2026Biokosmes SrlItalyA written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
Jun 26, 2026Natural Essentials IncorporatedUnited StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Jun 23, 2026Scinopharm Taiwan, Ltd.TaiwanInput to and output from the computer are not checked for accuracy.
Jun 12, 2026Epic Pharma, LLCUnited StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Jun 4, 2026Nexus Pharmaceuticals, LLCUnited StatesBackup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems.
Jun 3, 2026Eurofins SF Analytical Laboratories, Inc.United StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
May 29, 2026Pace Analytical Life Sciences, LLCUnited StatesInput to and output from related systems of formulas and records or data are not checked for accuracy.
May 15, 2026Emcure Pharmaceuticals LimitedIndiaAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
May 15, 2026Unither Manufacturing LLC.United StatesInput to and output from the computer, related systems of formulas and records or data are not checked for accuracy.
May 8, 2026Armstrong Pharmaceuticals, Inc.United StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
May 5, 2026Zydus Lifesciences LimitedIndiaAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
May 1, 2026Best Sanitizers IncUnited StatesInput to and output from the computer and records or data are not checked for accuracy.
May 1, 2026SnugZ USA, Inc.United StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Apr 28, 2026Micro Measurement Laboratories, Inc.United StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Apr 21, 2026Altaire Pharmaceuticals, Inc.United StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Apr 20, 2026New SPS Crossfolds, LLCUnited StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Apr 14, 2026Frontage Laboratories, Inc.United StatesFailure to maintain a backup file of data entered into the computer or related system.
Apr 9, 2026Lantheus Medical Imaging, Inc.United StatesAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

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