# FDA 483 - Alps Pharmaceutical Industrial Co., Ltd. - April 05, 2019

Source: https://www.keypedia.com/records/483/alps-pharmaceutical-industrial-co-ltd/ef3d3312-155d-4c2b-8291-14ee3a8c18da

> FDA 483 for Alps Pharmaceutical Industrial Co., Ltd. on April 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alps Pharmaceutical Industrial Co., Ltd.
- Inspection Date: 2019-04-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food East V Compliance Branch
- Summary: Alps Pharmaceutical Ind. Co. Ltd, an API manufacturer in Hida, Gifu, Japan, was cited for multiple quality system deficiencies during an FDA inspection. Observations included failures in equipment cleaning, inadequate cleaning procedures, lack of studies on product contact surfaces, insufficient stability data for API retest dates, and incomplete investigations into product discrepancies and complaints. These issues indicate a need for improved quality control and adherence to manufacturing standards.

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Company: https://www.keypedia.com/companies/alps-pharmaceutical-industrial-co-ltd/b7368086-4ecc-4cbe-b942-494bb1340c79

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-east-v-compliance-branch/00f6013b-7c92-4daf-ae51-d47ab44bf1cb