FDA 483 OBSERVATION · #486 OF 1,000 MOST-CITED
Complete instructions, procedures, specifications et. al.
FDA cited this observation 39 times across 38 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
Master production and control records lack complete manufacturing and control instructions.
Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures.
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures and specifications.
Master production and control records lack complete manufacturing and control instructions.
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations and precautions to be followed.
Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures.
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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