Data integrity continued to be a focus of the FDA, though the reduced inspections definitely led to fewer 483s.
| Reference Number | Short Description | Long Description | 2020 Frequency | 2019 Frequency | 2018 Frequency |
| 21 CFR 211.194(a) | Complete test data included in records | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , *** | 15 | 38 | 33 |
| 21 CFR 211.194(a)(4) | Complete Test Data | Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, *** | 10 | 24 | 28 |
| 21 CFR 211.68(b) | Backup data not assured as exact and complete | Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, *** | 6 | 6 | 71 |
| 21 CFR 211.194(a)(4) | Data secured in course of each test | Laboratory 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, *** | 4 | 1 | 28 |
| 21 CFR 211.68(b) | Written record not kept of program and validation data | A 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, *** | 1 | 6 | 71 |
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