Inspection Record

Taenaka Kogyo Co., Ltd. — FDA 483 Findings

US FDAInspected 2024-04-12Published 2024-09-06 4 findingsEquipment and facilityOther quality systemValidation and qualification

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

Findings

1Equipment and facility

Facilities for the storage ofmaterials under controlled temperature and humidity conditions are not sufficiently monitored to ensure the material characteristics of items stored inside them are maintained.

2Other quality system

Testing designed to ensure that API specifications for microbiological purity and appropriate action limits for total microbial counts and objectionable organisms are met is not conducted in a way that ensures the validity ofresults.

3Validation and qualification

Training is not regularly conducted by qualified individuals, does not cover the particular operations that employees perform and GMP as it relates to the employees' functions, and is not periodically assessed.

4Equipment and facility

Ventilation systems, including equipment for control of air pressure, are not adequately designed and constructed to minimize risks of contamination.

About this record

Extracted automatically from the document US FDA published on 2024-09-06. 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.

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