FDA 483 OBSERVATION · #235 OF 1,000 MOST-CITED
Written procedures - establish; returned dietary supplements
FDA cited this observation 97 times across 97 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 establish written procedures for when a returned dietary supplement is received.
You did not establish written procedures for when a returned dietary supplement is received, when a returned dietary supplement must be destroyed, or otherwise suitably disposed, when a returned dietary supplement may be salvaged and for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement.
You did not establish written procedures for when a returned dietary supplement is received.
You did not establish written procedures for when a returned dietary supplement is received and for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement.
You did not establish written procedures for when a returned dietary supplement is received.
You did not establish written procedures for when a returned dietary supplement is received.
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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