# FDA 483 - Aso Pharmaceutical Company, Ltd - September 08, 2023

Source: https://www.globalkeysolutions.net/records/483/aso-pharmaceutical-company-ltd/73fcc33f-ff52-4412-8831-32e50b4021cc

> FDA 483 for Aso Pharmaceutical Company, Ltd on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aso Pharmaceutical Company, Ltd
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aso Pharmaceutical Company, Ltd. in Kikuchi-Gun, Japan, a contract manufacturer, received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in laboratory controls, including a lack of specifications for impurities and microbial limits, and inadequate investigations into out-of-specification results and complaints. Other issues included undocumented deviations from procedures, insufficient process validation, poor facility maintenance, and a stability program that does not use the marketed container-closure system.

## Related Officers

- [Teresa I. Navas](https://www.globalkeysolutions.net/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.globalkeysolutions.net/companies/aso-pharmaceutical-company-ltd/7ed18d4d-08bf-4d5f-bdd9-c9feed7298af

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