Inspection Record
Inspectors Zakaria I GaniyuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations for its intended use and cleaning and maintenance.
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
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