FDA 483 OBSERVATION · #867 OF 1,000 MOST-CITED
Adequate lab facilities not available
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
Adequate lab facilities for testing and approval or rejection of drug products are not available to the quality control unit.
Adequate lab facilities for testing and approval or rejection of components, in-process materials and drug products are not available to the quality control unit.
Adequate lab facilities for testing and approval or rejection of drug products are not available to the quality control unit.
Adequate lab facilities for testing and approval or rejection of drug products are not available to the quality control unit.
Adequate lab facilities for testing and approval or rejection of in-process materials and drug products are not available to the quality control unit.
Adequate lab facilities for testing and approval or rejection of in-process materials and drug products are not available to the quality control unit.
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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