# FDA 483 - OHM Pharma, Inc. - May 23, 2019

Source: https://www.keypedia.com/records/483/ohm-pharma-inc/f91c848c-05db-4a77-99c6-3616f437ae35

> FDA 483 for OHM Pharma, Inc. on May 23, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: OHM Pharma, Inc.
- Inspection Date: 2019-05-23
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: OHM PHARMA INC. in Mineral Wells, TX, a manufacturer of homeopathic drugs, received a Form 483 with significant observations related to quality control, laboratory practices, and manufacturing processes. The inspection revealed deficiencies in documentation, investigation of out-of-specification results, control of records, equipment calibration, and process validation. These issues indicate a lack of adequate controls to ensure the quality, purity, and safety of their drug products.

## Related Documents

- [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)
- [483 - 2025-04-29](https://www.keypedia.com/records/483/ohm-pharma-inc/0e3c0e4a-7131-4158-9648-6d81a14f82da)

## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

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