# FDA 483 - P.T. Sankei Medical Industries - May 11, 2023

Source: https://www.globalkeysolutions.net/records/483/pt-sankei-medical-industries/70af8302-2a58-4965-9224-cfb680ac3aa8

> FDA 483 for P.T. Sankei Medical Industries on May 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: P.T. Sankei Medical Industries
- Inspection Date: 2023-05-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: P.T. Sankei Medical Industries, a medical device manufacturer in Serang, Indonesia, was inspected by the FDA and received eight observations. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for design control, corrective and preventive actions, purchasing, complaint handling, and medical device reporting. The firm also failed to adequately maintain device history and master records and lacked proper quality audit documentation.

## Related Documents

- [WARNING_LETTER - 2023-05-11](https://www.globalkeysolutions.net/records/warning_letter/pt-sankei-medical-industries/e01538a1-ccc4-46b6-b20b-c8a480b76da1)

## Related Officers

- [Thai T. Duong](https://www.globalkeysolutions.net/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.globalkeysolutions.net/companies/pt-sankei-medical-industries/dc3fa15f-5914-4765-82ca-1c46477bcf51

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