FDA 483 OBSERVATION · #342 OF 1,000 MOST-CITED
Procedures to meet core CTGP
FDA cited this observation 61 times across 58 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
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not followed.
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not established.
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not followed.
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not followed.
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not established, maintained and defined.
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not established and maintained.
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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