# FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - August 03, 2017

Source: https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/50a62d71-bc66-4dc8-8812-78e3e9f52204

> FDA 483 for GLPGCP Development (Asia) Pte. Ltd. on August 03, 2017. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GLPGCP Development (Asia) Pte. Ltd.
- Inspection Date: 2017-08-03
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of TELEMED, a manufacturer in Vilnius, Lithuania, from July 31 to August 3, 2017, identified 18 significant deficiencies. The observations highlight a widespread lack of established procedures across critical quality system areas, including complaint handling, design control, process control, and training. This indicates a fundamental breakdown in the firm's quality management system.

## Related Documents

- [483 - 2017-06-22](https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/8bad919d-c1b6-4fee-b805-fadc9ef0faa4)
- [483 - 2026-05-18](https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/3a0a3c58-fa17-4496-9fd8-425c92f62a60)
- [483 - 2018-04-19](https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/4fd7e91c-468e-4aed-8198-505eaef4128a)
- [483 - 2026-01-30](https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/3a2a3d7b-ae6a-487c-9a90-0d731754259a)

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd