# FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - April 19, 2018

Source: https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/4fd7e91c-468e-4aed-8198-505eaef4128a

> FDA 483 for GLPGCP Development (Asia) Pte. Ltd. on April 19, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GLPGCP Development (Asia) Pte. Ltd.
- Inspection Date: 2018-04-19
- Product Type: device
- Office Name: FDA District Office — Silver Spring, Unknown
- Summary: An FDA inspection of Humanoptics Ag., a manufacturer in Sankt Augustin, Germany, identified two significant issues. The firm was cited for inadequate validation of processes where results cannot be fully verified by subsequent inspection and test. Additionally, procedures for corrective and preventive action were found to be inadequately established.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/glpgcp-development-asia-pte-ltd/1f245fd5-d660-4d72-8019-5e993c078d9e

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-spring-unknown/5b075d23-f009-4607-9522-94e8124c6d14