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# OHM Inspection Finds CGMP Issues
- URL: https://www.fdaweb.com/ohm-inspection-finds-cgmp-issues/
- Published: 2019-12-10T12:00:00.000Z
- Updated: 2026-09-14T15:56:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145690

A 5/14-5/23 FDA inspection at OHM Pharma, Mineral Wells, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/19 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ohm-pharma-inc-586428-11192019?ref=fdaweb.com). Specific violations were: 

- failing to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition;
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to establish adequate written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and the firm’s quality control unit did not review and approve the procedures, including any changes.

Based upon the nature of the violations found in the inspection, FDA strongly recommends that OHM engage a qualified consultant to assist it in meeting CGMP requirements. The letter also lists several examples of adulterated and misbranded dietary supplements and makes several additional comments about OHM’s dietary supplement products.

The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the actions.