4.3 - Equipment Program of Maintenance stability You must keep written records

You must keep written records required by this part for 1 year past the shelf life date

or break under compression during storage or transport

or other extraneous material

Failure to meet any specification must be investigated by Quality Control

to determine whether or not they involve a possible failure of a dietary supplement to meet any of its specifications

4.3 - Equipment Program of Maintenance stability You must keep written recordsEquipment must be adequately maintained as part of a preventive maintenance program to protect components and dietary supplements from being contaminated by any source, to ensure that it functions in accordance with its intended use, and is capable of operating satisfactorily within the operating limits required by the process