FDA 483 - Precision Dose Inc. - September 11, 2025
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Precision Dose Inc., a repackager in South Beloit, IL, was cited for significant deficiencies in its quality control unit, specifically regarding the inconsistent handling of customer complaint investigation extensions, which was a repeat observation. Additionally, the firm failed to properly identify drug products, batch numbers, and processing phases on major equipment and production lines during repackaging activities. These issues indicate a lack of adequate control over critical quality and manufacturing processes.
ID · 4273071e-3fed-4a19-9548-70b2221c37ca