# FDA 483 - Strata Skin Sciences, Inc. - August 22, 2024

Source: https://www.globalkeysolutions.net/records/483/strata-skin-sciences-inc/aa9a1cab-6f6b-4875-9d02-92c5974e1868

> FDA 483 for Strata Skin Sciences, Inc. on August 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Strata Skin Sciences, Inc.
- Inspection Date: 2024-08-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Strata Skin Sciences, Inc. in Carlsbad, CA, a medical device manufacturer, received one FDA Form 483 observation following an inspection. The observation cited inadequate documentation and approval of process validation activities for their XTRAC Laser System AL10000. This indicates a deficiency in their quality system regarding manufacturing process controls.

## Related Documents

- [WARNING_LETTER - 2011-08-22](https://www.globalkeysolutions.net/records/warning_letter/strata-skin-sciences-inc/9cad42cd-5838-4b69-a416-2090f6282120)
- [483 - 2015-06-16](https://www.globalkeysolutions.net/records/483/strata-skin-sciences-inc/6eb31697-679a-49ef-8190-b066a955b0e0)
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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

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

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