Recipient: Alternative Health & Herbs Remedies
Product: Squaw Vine, Parsley Herb, Mistletoe (European) and other tinctures
Date: 3/17/05

Failure to exercise strict controls over labeling issued for use in drug product labeling operations [21 CFR 211.125(a)]. Specifically, your firm currently does not issue labels, review them for accuracy, or reconcile them; any extra labels from a labeling campaign are stored under the labeling area in cardboard boxes for use with future lots of drug product. Furthermore, the original labeling stored on your computer database has not been reviewed or approved for accuracy. In addition, your firm fails to have adequate SOP’s for review and approval of labels for finished drug products.

FDA District: Seattle District Office