Inspection Record

First Cah Co., Ltd. — FDA 483 Findings

US FDAInspected 2023-10-27Published 2024-09-23 6 findingsLaboratory and QC controlsMaterial and supplier controlStability and storageTraining and personnelQuality unit oversight

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

Findings

1Laboratory and QC controls

The suitability of all testing methods is not verified under actual conditions ofuse.

2Material and supplier control

Specific identification tests are not conducted on components that have been accepted based on the supplier's repo1t of analysis.

3Stability and storage

There is no written testing program designed to assess the stability characteristics of diug products.

4Training and personnel

GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

5Quality unit oversight

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

6Laboratory and QC controls

Dmg products failing to meet established specifications and quality control criteria are not rejected.

About this record

Extracted automatically from the document US FDA published on 2024-09-23. 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.

First Cah Co., Ltd. company profile — full history US FDA documents, 2024 Go to Findings search