FDA Warning Letter for not Adequately Testing Components prior to Use in the Manufacture

Recommendation

17/18 June 2021

Live Online Training: Reduced Sampling - Reduced Testing

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated November 4, 2020, to Nartex Laboratorios Homeopaticos S.A. de C.V. During an inspection from February 24 to 28, 2020, at the company's manufacturing facility in Mexico, the FDA found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

No Adequate Process Validation and Equipment Qualification

According to the FDA, the firm did neither adequately validate the process nor qualify the equipment used to manufacture their drug products.

In the Warning Letter, the FDA said that during the inspection, the company provided the investigator with a signed statement acknowledging that the company had not performed any process validation or equipment validation for various homeopathic drug products distributed to the United States.

The FDA concludes that because several of the drug products produced for the U.S. market contain potentially toxic ingredients, the failure to validate processes to identify and control sources of variation could place consumers at risk.

The FDA emphasizes: "Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle."

No Adequate Testing of Components prior to use in the Manufacture

During the inspection, it was observed that the company did not adequately test components prior to use in the manufacture of drug products destined for the US market. Nartex Laboratorios Homeopaticos conducted identity testing on incoming lots of components, but relied on the supplier certificates of analysis (COA) for conformity with all other appropriate written specifications for purity, strength, and quality.

In response to the warning letter, the FDA asked to provide, besides others, a description of how each component lot will be tested for conformity with all appropriate specifications for identity, strength, quality, and purity. The FDA points out that if it is intended to accept any results from a supplier’s COA instead of testing each component lot for strength, quality, and purity, the company must specify how it will robustly establish the reliability of the supplier’s results through initial validation as well as periodic re-validation.

The Warning Letter to the Mexican manufacturer can be found on the FDA website.