Drugs

Multiple Dietary Supplement Violations at PRL

A 10/16-10/26/18 FDA inspection at PRL, Inc., Lobelville, TN, found multiple serious violations of agency regulations for current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. A 6/6 Warning Letter says the violations cause the dietary supplements manufactured at the firm’s facility to be adulterated. The letter also says the agency investigator collected labels for the firm’s dietary supplements and a review of the labels and the PRL Web site shows serious violations of the Federal Food, Drug, and Cosmetics Act and applicable regulations.

The letter addresses issues involving unapproved new/misbranded drugs and adulterated dietary supplements. It identifies significant CGMP violations as:

failing to establish product specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement and for limits on those types of contamination that may adulterate, or may lead to adulteration of, the finished batch of the dietary supplement to ensure supplement quality;
failing to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that the company used the specified packaging and applied the specified label;
failing to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient before use in the manufacture of dietary supplement products;
failure of quality control personnel to approve or reject written procedures that may affect the identity, purity, strength, or composition of a dietary supplement;
failure of the master manufacturing record to include all required information;
failure of batch production records to include all required information;
failing to calibrate instruments or controls used in manufacturing or testing a component or dietary supplement;
failing to control issuance and use of labels; and
failing to make and keep records of any test or examinations conducted on packaging or labels and of any visual examination of product received for packaging or labeling as a dietary supplement and any material review and disposition decision on components, packaging, labels, or products received for packaging or labeling as a dietary supplement.

PRL was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation for each step and a timetable for completion.

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