2020 483s on data integrity

Data integrity continued to be a focus of the FDA, though the reduced inspections definitely led to fewer 483s.

Reference NumberShort DescriptionLong Description2020 Frequency2019 Frequency2018 Frequency
21 CFR 211.194(a)Complete test data included in recordsLaboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.  Specifically, , ***153833
21 CFR 211.194(a)(4)Complete Test DataLaboratory records are deficient in that they do not include a complete record of all data obtained during testing.  Specifically, ***102428
21 CFR 211.68(b)Backup data not assured as exact and completeBackup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems.  Specifically, ***6671
21 CFR 211.194(a)(4)Data secured in course of each testLaboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product tested].  Specifically, ***4128
21 CFR 211.68(b)Written record not kept of program and validation dataA 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.  Specifically, ***1671
483s related to data integrity

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