1Material and supplier control
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Inspection Record
AnazaoHealth Corporation — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
3Laboratory and QC controls
The accuracy, sensitivity, specificity, and reproducibil ity of test methods have not been established and d ocumented.
About this record
Extracted automatically from the document US FDA published on 2022-11-21. 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.
