4.0 - Equipment Design and Construction reprocess the lot and any other

the lot and any other implicated lots must be quarantined and an out of specification (OOS) investigation conducted to determine the validity of the result

comply with applicable Federal

environment

Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records

4.0 - Equipment Design and Construction reprocess the lot and any otherFor the production of dietary supplements you must use equipment and utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained thus preventing cross contamination