# FDA 483 - SOHM Inc. - November 05, 2024

Source: https://www.globalkeysolutions.net/records/483/sohm-inc/3408d4e8-864b-4aea-ba87-707f06093fef

> FDA 483 for SOHM Inc. on November 05, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SOHM Inc.
- Inspection Date: 2024-11-05
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: SOHM, Inc. in Carlsbad, CA, was inspected regarding its manufacturing of OTC drug products, Salicylic Acid 2% and Hydroquinone USP 4%. The inspection revealed significant deficiencies across its quality system, including inadequate production and process controls, a non-existent quality control unit, and poor equipment and labeling management. These issues indicate a severe lack of adherence to cGMP regulations, potentially impacting drug product quality, safety, and purity.

## Related Officers

- [Rawna D Brown](https://www.globalkeysolutions.net/people/rawna-d-brown/18a99ec6-c828-4dc8-ab43-f7f0da8a2b22)
- [Mercedes N. Overton](https://www.globalkeysolutions.net/people/mercedes-n-overton/d3c24898-20d4-45f8-adda-24431066c9e6)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)
- [Dawnna D. Brown](https://www.globalkeysolutions.net/people/dawnna-d-brown/a489bd7b-733f-4dd5-994c-357cb5a5ce85)

Company: https://www.globalkeysolutions.net/companies/sohm-inc/31b14738-3ae6-41fd-82c3-9609f9f6a70b

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b