FDA 483 OBSERVATION · #941 OF 1,000 MOST-CITED
Bacteriological swab, rinse count - containers, closures (S)
FDA cited this observation 18 times across 18 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
You did not take a bacteriological swab or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing.
You did not take a bacteriological swab or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing.
You did not take a bacteriological swab or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing.
You did not take a bacteriological swab or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing.
You did not take a bacteriological swab or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing.
You did not take a bacteriological swab or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing.
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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