The FDA requires that packaging, labeling and holding companies be able
to prove that products they are labeling, packaging or holding were
manufactured in accordance with the FDA regulations. The regulations do
not say specifically what records are needed, but being the last to
touch the product before the customer, it is their responsibility to
gather and have readily available all data such as COAs, specs and
testing results, MPR recipe, batch manufacturing signatures in case of a
recall or audit.
