# FDA 483 - SMC Ltd. - February 08, 2019

Source: https://www.globalkeysolutions.net/records/483/smc-ltd/7f21ea2e-78f4-4bb7-b5e0-1d1ece0d3089

> FDA 483 for SMC Ltd. on February 08, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SMC Ltd.
- Inspection Date: 2019-02-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: SMC Ltd. in Santa Rosa, CA, received a Form FDA 483 with two observations. The inspection revealed inadequate validation of manufacturing processes for subassemblies and deficiencies in the firm's corrective and preventive action (CAPA) procedures, specifically regarding verification of effectiveness. These issues indicate potential weaknesses in the firm's quality system for medical device manufacturing.

## Related Officers

- [Regulatory Review Officer](https://www.globalkeysolutions.net/people/quynh-strandberg/9b582ae6-85f9-4163-8ce6-b179c5fd340e)

Company: https://www.globalkeysolutions.net/companies/smc-ltd/0b3c0c0d-7873-4e84-b288-9f064c18ead8

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b