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# CGMP Violations at Stason Pharmaceuticals
- URL: https://www.fdaweb.com/cgmp-violations-at-stason-pharmaceuticals/
- Published: 2020-07-21T12:00:00.000Z
- Updated: 2026-09-14T16:22:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147235

A 10/3-10/25/19 FDA inspection at Stason Pharmaceuticals, Irvine, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/8 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stason-pharmaceuticals-inc-604889-07082020?ref=fdaweb.com) says specific violations 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; 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 says that based on the nature of the violations identified at the firm, FDA recommends that Stason engage a qualified consultant to assist it in meeting CGMP requirements.

Stason was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completing the actions.