# FDA 483 - OHM Pharma, Inc. - July 29, 2022

Source: https://www.keypedia.com/records/483/ohm-pharma-inc/40a4ead1-360e-49b1-b064-d319146a1a9a

> FDA 483 for OHM Pharma, Inc. on July 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OHM Pharma, Inc.
- Inspection Date: 2022-07-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: OHM Pharma, Inc. in Mineral Wells, TX, was cited with six observations on a Form 483 following an inspection of its dietary supplement manufacturing facility. The firm failed to establish and follow product specifications, released out-of-specification products, and did not adequately confirm component identity or use scientifically valid testing methods. Additionally, deficiencies were noted in master manufacturing records and hand-washing facilities, with several issues being repeat observations.

## 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)
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## Related Officers

- [Denise Connelly](https://www.keypedia.com/people/denise-connelly/cb196412-348c-4f66-9347-3fdec6d2e3bc)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab