RE- MANUFACTURER S APPLICATION FOR APPROVAL 2025

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Rework is the process of correcting defective, failed, or nonconforming items after inspection. This process includes disassembly, repair, replacement, and reassembly.
Rework, on the other hand, involves modifying the process with additional steps not originally included in the validated manufacturing process. This is done to correct defects or deviations that cannot be addressed by simply repeating existing procedures.
Rework is an unincorporated food product kept for subsequent use or reprocessing. Examples of reworking may include: re-forming meat patties rejected for being broken, underweight or improperly breaded.
Measures in the bill are intended to prevent pharmaceutical companies from blocking companies from producing generic drugs by refusing to sell drugs to the new companies, or taking advantage of safety regulation to block new drugs. Generic drug companies would be allowed to sue to gain access to samples.
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