FDA 483 OBSERVATION · #164 OF 1,000 MOST-CITED
Buildings not maintained in good state of repair
FDA cited this observation 145 times across 135 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
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.
Buildings used in the processing of a drug product are not maintained in a good state of repair.
Buildings used in the holding of a drug product are not maintained in a good state of repair.
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
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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