# FDA 483 - OHM Pharma, Inc. - April 29, 2025

Source: https://www.keypedia.com/records/483/ohm-pharma-inc/0e3c0e4a-7131-4158-9648-6d81a14f82da

> FDA 483 for OHM Pharma, Inc. on April 29, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OHM Pharma, Inc.
- Inspection Date: 2025-04-29
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of OHM Pharma, Inc. in Mineral Wells, TX, a manufacturer of non-sterile liquid OTC drug products, intermediates, and APIs, revealed significant deficiencies. The firm failed to establish adequate cleaning procedures, use appropriately designed equipment, perform process validation, and implement a stability monitoring program. These observations indicate serious concerns regarding the firm's manufacturing controls and product quality.

## Related Documents

- [483 - 2019-05-23](https://www.keypedia.com/records/483/ohm-pharma-inc/f91c848c-05db-4a77-99c6-3616f437ae35)
- [WARNING_LETTER - 2019-05-23](https://www.keypedia.com/records/warning_letter/ohm-pharma-inc/42e03125-8992-49df-a99f-92d9c8561e64)
- [483 - 2020-03-18](https://www.keypedia.com/records/483/ohm-pharma-inc/7035bda3-166d-4496-b16b-80bbab7337b0)

## Related Officers

- [Microbiologist](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)
- [Consumer Safety Officer](https://www.keypedia.com/people/nadeem-i-chaudhry/7d867939-2dc6-4503-b9b9-6f26b16c347e)

Company: https://www.keypedia.com/companies/ohm-pharma-inc/c3ecfcf1-4d7d-4404-be13-ea1bdc864d14

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9