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# Multiple Violations at Humco Holding Group
- URL: https://www.fdaweb.com/multiple-violations-at-humco-holding-group/
- Published: 2017-02-21T12:00:00.000Z
- Updated: 2026-09-14T22:07:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138018

A 6/25-7/1/15 FDA inspection at Humco Holding Group, Texarkana, TX, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 1/26 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm541308.htm?ref=fdaweb.com) from the agency’s Dallas District Office. The inspection also found that the firm manufactures and distributes unapproved new drugs and that some of the drugs it manufactures are misbranded.

Unapproved new drugs identified during the inspection were Humco cherry flavored potassium chloride oral solution and Shohl’s Solution (Modified), sodium citrate and citric acid oral solution. The letter says the two products are not generally recognized as safe and effective for use according to their labeling and there are no FDA-approved applications on file for them.

The two unapproved new drugs also are misbranded, the letter says, because they are considered prescription drugs in light of their toxicity or potential for harmful effects, the method of their use, or the collateral measures necessary for their use. Because the two drugs are not safe for use except under the supervision of a licensed practitioner, adequate directions cannot be written to that a layperson could use them for their intended uses and thus they are misbranded., FDA says

The letter addresses an unidentified over-the-counter drug product that FDA says is misbranded because it is false or misleading and because it is a danger to health when used in the dosage or manner prescribed, recommended, or suggested in the labeling.

Specific CGMP deficiencies identified in the inspection included: 

- failing to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

 The District Office recommended that the company engage a third-party consultant with appropriate CGMP expertise to assess its facility, procedures, processes, and systems to ensure that the drugs it manufactures have the appropriate identity, strength, quality, and purity. Humco was told to take prompt action to correct the violations, including discontinuing the manufacture and distribution of unapproved drugs. It was told to respond with a list of steps taken to correct the violations and prevent their recurrence, documentation of each step, and a timetable for completion.