FDA 483 OBSERVATION · #990 OF 1,000 MOST-CITED
Instructions; specifications; packaged, labeled
FDA cited this observation 17 times across 17 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
The written instructions in your master manufacturing record did not include specifications for each point, step, or stage 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.
The written instructions in your master manufacturing record did not include specifications for each point, step, or stage 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.
The written instructions in your master manufacturing record did not include specifications for each point, step, or stage 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.
The written instructions in your master manufacturing record did not include specifications for each point, step, or stage 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.
The written instructions in your master manufacturing record did not include specifications for each point, step, or stage 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.
The written instructions in your master manufacturing record did not include specifications for each point, step, or stage 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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