You failed to ascertain specs for your dietary supplement labels (label specifications) and for packaging which will come in contact with your dietary dietary supplements (packaging specs), as required by 21 CFR 111.70(d). Specifically, your operations supervisor informed our investigator that you have not established specifications for the labels and packaging used with your dietary supplement products. We have reviewed your November 12, 2013, and March 3, 2014, responses, during which you state that SOPs are presently being written to establish procedures for holding and distributing operations. However, your responses did not provide a replica of your written procedures in your holding and distributing operations.
Accordingly, FDA may assess charges to cowl any costs associated to re-inspection. This letter just isn’t supposed to be an all-inclusive record of violations at your facility or that exist in connection together with your products or their labeling.
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