FDA 483 OBSERVATION · #855 OF 1,000 MOST-CITED
Data secured in course of each test
FDA cited this observation 17 times across 17 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
How FDA worded it — real examples
Laboratory records do not include a complete record of all data secured in the course of each test, including all charts and spectra from laboratory instrumentation, properly identified to show the.
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts and spectra from laboratory instrumentation, properly identified to show the specific component, in-process material, lot tested and drug product tested.
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts and spectra from laboratory instrumentation, properly identified to show the lot tested and drug product tested.
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts and spectra from laboratory instrumentation, properly identified to show the specific component, in-process material, lot tested and drug product tested.
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts and spectra from laboratory instrumentation, properly identified to show the specific component and drug product tested.
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts and spectra from laboratory instrumentation, properly identified to show the in-process material, lot tested and drug product tested.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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