FDA 483 OBSERVATION · #881 OF 1,000 MOST-CITED
Containers & Closures Clean, Sterilized, Pyrogen-free
FDA cited this observation 21 times across 19 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
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Drug product containers were not clean to assure that they are suitable for their intended use.
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Drug product closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Drug product containers were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
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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