Drugs

CGMP Violations at Natural Beauty Care

FDA says its review of records submitted by Natural Beauty Care Pty Ltd, a Victoria, Australia, manufacturer of over-the-counter drug products, revealed significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released Warning Letter says specific violations were:

failing to have for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
failing to conduct at least one test to verify the identity of each component of a drug product; and
failing to establish and follow an adequate written testing program designed to access the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

The letter says the firm acknowledged it does not have process flow diagrams showing critical control points for each finished drug product manufactured at its facility. “Without identifying critical process parameters and an ongoing program for monitoring process controls,” FDA says, “you are unable to ensure stable manufacturing operations and consistent drug quality.” FDA also says the firm’s quality systems are inadequate.

The agency strongly recommends that Natural Beauty engage a consultant to assist it in meeting CGMP requirements after performing a comprehensive audit of its operations for CGMP compliance. The consultant should also evaluate the completion and efficacy of the company’s corrective and preventive actions before it pursues resolution of its compliance status with FDA.

Natural Beauty was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome