# FDA 483 - Taenaka Kogyo Co., Ltd. - April 12, 2024

Source: https://www.keypedia.com/records/483/taenaka-kogyo-co-ltd/0152064a-8116-485b-a60f-3e4ac56fb420

> FDA 483 for Taenaka Kogyo Co., Ltd. on April 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Taenaka Kogyo Co., Ltd.
- Inspection Date: 2024-04-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Taenaka Kogyo Co., Ltd., an active pharmaceutical ingredient manufacturer in Mobara, Chiba, Japan, was cited for significant deficiencies during an FDA inspection. Observations included inadequate employee training and assessment for visual inspection, poorly designed ventilation systems leading to contamination risks, and insufficient monitoring of temperature-controlled storage. Additionally, the firm's microbiological purity testing was found to be invalid due to inadequate growth promotion testing of media plates.

## Related Documents

- [483 - 2024-04-12](https://www.keypedia.com/records/483/taenaka-kogyo-co-ltd/bb6fd983-814c-4d94-b9a2-b30d5147090e)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/taenaka-kogyo-co-ltd/81821784-e9ae-463f-9ab9-29a5c7605880

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1