Drugs

Essential Pharmaceutical Adulterated, Misbranded Supplements

A 10/8-10/17/19 FDA inspection at Essential Pharmaceutical Corp., Pomona, CA, found the company produces adulterated and misbranded dietary supplements as well as an unapproved new drug. A 9/3 Warning Letter lists specific violations as:

manufacturing an unapproved new drug and marketing it as an over-the-counter product;
failing to establish identity specifications for each component used in the manufacture of a dietary supplement;
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;
failing to establish specifications for dietary supplement labels;
failing to establish and follow all required written procedures for the responsibilities of the quality control operation, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting reprocessing;
failing to prepare a master manufacturing record that includes information specified in regulations;
failing to prepare a batch production record every time the company manufactures a batch of dietary supplements with the information required by regulations; and
failing to maintain, clean, and sanitize equipment and contact surfaces used to manufacture or hold components of dietary supplements.

The letter also lists the firm’s dietary supplements that FDA says are misbranded because they don’t comply with labeling requirements.

Essential was told to respond with a list of specific actions it is taking to correct the violations and prevent their recurrence, with documentation of the actions and an implementation schedule.

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