FDA 483 OBSERVATION · #626 OF 1,000 MOST-CITED
Supply-Chain Written Procedures for Receiving Raw Materials
FDA cited this observation 28 times across 28 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, implement and document the use of written procedures for receiving raw materials and other ingredients.
You did not establish, implement and document the use of written procedures for receiving raw materials and other ingredients.
You did not implement written procedures for receiving raw materials and other ingredients.
You did not implement written procedures for receiving raw materials and other ingredients.
You did not implement written procedures for receiving raw materials and other ingredients.
You did not establish and implement written procedures for receiving raw materials and other ingredients.
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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