FDA 483 - AAA Pharmaceutical, Inc. - March 28, 2025
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An FDA inspection of AAA Pharmaceutical, Inc. in Lumberton, NJ, an OTC Drug Repacker/Control Testing Laboratory, revealed significant deficiencies in its stability testing program. The firm failed to follow its written procedures by missing critical stability testing timepoints for drug products. Furthermore, the company's stability study procedures and protocols were found to be inadequate, lacking provisions for missed timepoints and proper justification for early sample pulls.
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ID · 26bf10f7-11e8-4c0a-bc7f-87be30347209