# FDA 483 - SNS Biosystems - June 24, 2022

Source: https://www.keypedia.com/records/483/sns-biosystems/1bd2d0c2-1ed2-4501-ac92-9f274a41d499

> FDA 483 for SNS Biosystems on June 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SNS Biosystems
- Inspection Date: 2022-06-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: SNS Biosystems, a Class II medical device manufacturer in Santa Maria, CA, was inspected by the FDA. The inspection revealed two significant issues: inadequate labeling examination, specifically regarding Unique Device Identifiers for spore strips, and a lack of documentation for equipment calibrations. These observations indicate deficiencies in quality system procedures.

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Company: https://www.keypedia.com/companies/sns-biosystems/25bd5193-c1e7-4f84-840e-402f27bd0312

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6