Inspection Record

Ajinomoto Althea, Inc. — FDA 483 Findings

US FDAInspected 2023-01-16Published 2023-04-25 3 findingsEquipment and facilityQuality unit oversightValidation and qualification

Inspectors Christopher R. CzajkaThe inspectors who signed the published document.Inspector lookup

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

Findings

1Equipment and facility

Facility and Equipment maintenance are deficient in their ability to support cGMP production activities.

2Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

3Validation and qualification

Quality oversight of validation activities is inadequate.

About this record

Extracted automatically from the document US FDA published on 2023-04-25. 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.

Ajinomoto Althea, Inc. company profile — full history US FDA documents, 2023 Go to Findings search