FDA 483 OBSERVATION · #795 OF 1,000 MOST-CITED
Master manufacturing record-specifications; packaged, label
FDA cited this observation 24 times across 23 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
Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
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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