# FDA 483 - SOPRO - July 21, 2022

Source: https://www.keypedia.com/records/483/sopro/1c574ef9-d4e9-4e58-afc7-bb58c66c31b0

> FDA 483 for SOPRO on July 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SOPRO
- Inspection Date: 2022-07-21
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of SOPRO, a medical device manufacturer in La Ciotat cedex, France, revealed three significant observations. The firm failed to adequately establish procedures for complaint handling, lacked evidence of shipping validation for its S640 and Symbioz Flow Laparoscopic Insufflators, and utilized sampling plans not based on valid statistical rationale. These findings indicate deficiencies in the firm's quality system.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/sopro/329d6199-0326-4db0-8eb0-86c71d454448

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