FDA 483 OBSERVATION · #833 OF 1,000 MOST-CITED
Homeopathic drugs, assessment of stability
FDA cited this observation 22 times across 20 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
There is no written assessment of stability of homeopathic drug products based at least on marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use.
There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients.
There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients and marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use.
There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients.
There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients.
There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the 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.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.