Drugs

3 CGMP Violations at Naturich Cosmetique

A 4/28-5/2 FDA inspection at the Naturich Cosmetique drug manufacturing facility in Garland, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/25 Warning Letter says the specific violations were:

failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
failure to conduct at least one test to verify the identity of each component of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals.

The letter says Naturich’s quality systems are inadequate. The agency recommends that the company engage a qualified consultant to evaluate its operation for CGMP compliance and assist it in meeting CGMP requirements.

The letter reminds Naturich that it is responsible for the quality of drugs it produces as a contractor, regardless of agreements in place with product owners. It also says that some of the firm’s products may be regulated as cosmetics.

Naturich was told to correct violations promptly and to respond with a list of specific actions it has taken to address 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