# FDA 483 - Strata Skin Sciences, Inc. - September 30, 2021

Source: https://www.keypedia.com/records/483/strata-skin-sciences-inc/0102f065-6033-4790-9c60-1505b565ca13

> FDA 483 for Strata Skin Sciences, Inc. on September 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Strata Skin Sciences, Inc.
- Inspection Date: 2021-09-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Strata Skin Sciences, Inc., a medical device manufacturer in Carlsbad, CA, revealed two significant quality system deficiencies. The firm failed to establish procedures for valid statistical techniques in process and product control, leading to incorrect sampling during incoming inspections. Additionally, equipment maintenance schedules were not adequately established, resulting in overdue preventative maintenance.

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## Related Officers

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Company: https://www.keypedia.com/companies/strata-skin-sciences-inc/593e4318-f3ce-402a-a9cb-da6b2e9086d7

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