FDA 483 OBSERVATION · #202 OF 1,000 MOST-CITED
Sanitation--buildings not clean, free of infestation
FDA cited this observation 115 times across 110 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 manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
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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