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# CGMP Violations at Adamson Analytical Labs
- URL: https://www.fdaweb.com/cgmp-violations-at-adamson-analytical-labs-2/
- Published: 2016-08-09T12:00:00.000Z
- Updated: 2026-09-14T21:22:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136450

An 8/4-8/14/15 FDA inspection at Adamson Analytical Laboratories, Corona, CA, identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to an 8/2 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514910.htm?ref=fdaweb.com) from the agency’s Los Angeles District Office. Specific violations and deviations included: 

- failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records;
- 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
- failure of the firm’s quality unit to ensure that materials are appropriately tested and the results are reported.

The company was told to respond with a list of specific steps taken since the inspection to correct the violations and deviations and prevent their recurrence, documentation of each step, and a timetable for completion.