1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Inspection Record
AnazaoHealth Corporation — FDA 483 Findings
Inspectors Taichun QinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
3Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
4Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
About this record
Extracted automatically from the document US FDA published on 2025-09-02. 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.
