# FDA 483 - Surgitools Pty Ltd - April 17, 2019

Source: https://www.globalkeysolutions.net/records/483/surgitools-pty-ltd/94638e5b-e839-4fee-8a69-ebf3f7aceed9

> FDA 483 for Surgitools Pty Ltd on April 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgitools Pty Ltd
- Inspection Date: 2019-04-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: SurgiTools (Shanghai) Medical Instruments Co., Ltd. was inspected by the FDA from April 15-17, 2019, as a medical device manufacturer. The inspection revealed a significant issue regarding the lack of adequate documentation for the cleaning process of a clean room used for packaging medical devices. This indicates a lapse in environmental control procedures.

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.globalkeysolutions.net/companies/surgitools-pty-ltd/d528b745-a285-48b4-bbe5-0d1c15430634

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