Inspection Record

Auronext Pharma — FDA 483 Findings

US FDAInspected 2018-03-06Published 2018-05-17 3 findingsLaboratory and QC controlsTraining and personnelProcess validation

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

Findings

1Laboratory and QC controls

The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.

2Training and personnel

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

3Process 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.

About this record

Extracted automatically from the document US FDA published on 2018-05-17. 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.

Auronext Pharma company profile — full history US FDA documents, 2018 Go to Findings search