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# Apothecus Combination Product CGMP Issues
- URL: https://www.fdaweb.com/apothecus-combination-product-cgmp-issues/
- Published: 2019-11-19T12:00:00.000Z
- Updated: 2026-09-14T15:53:42.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5145533

A 4/15-4/30 FDA inspection at Apothecus Pharmaceutical, Hicksville, NY, found significant violations of current good manufacturing practice (CGMP) regulations for combination products. Specific violations listed in an 11/8 Warning Letter were: 

- 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;
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products; and
- failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records.

The letter reminds Apothecus that it is responsible for the quality of products it produces, regardless of any agreements with contractors. The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the steps.