Inspection Record

AnazaoHealth Corporation — FDA 483 Findings

US FDAInspected 2022-07-29Published 2022-11-21 3 findingsMaterial and supplier controlProcess validationLaboratory and QC controls

View the regulator's official source The source document is always the basis for judgement.

Findings

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.

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.

Other records for this company

2025-08-08 · US FDA · 4 findings2015-10-27 · US FDA · 14 findings2015-07-23 · US FDA · 4 findings2015-07-10 · US FDA · 12 findings2017-04-28 · US FDA · 6 findings2017-05-15 · US FDA · 6 findings
AnazaoHealth Corporation findings history — including this company's other documents US FDA documents, 2022 Go to Findings search