# FDA 483 - SHE IS ORGANIC LLC - October 29, 2019

Source: https://www.keypedia.com/records/483/she-is-organic-llc/03c953be-012d-41ba-81ae-1275fb5cccb8

> FDA 483 for SHE IS ORGANIC LLC on October 29, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SHE IS ORGANIC LLC
- Inspection Date: 2019-10-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of OHB IS ORGANIC LLC in Laguna Niguel, CA, revealed significant deficiencies in their quality system. The firm failed to establish procedures for corrective and preventive actions (CAPA) and for medical device reporting (MDR). These issues were noted while the firm has been importing and distributing She cotton tampons since late 2016.

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/she-is-organic-llc/7aa6e7b3-d024-4f0f-b582-61561f42a420

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