FDA Warning Letter: Root Cause of Benzene Contamination not unterstood

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. The document dated 20 April 2023 goes back to an inspection from 23 August to 02 September 2022 at a drug manufacturing facility in Indiana, USA. The company manufactures over-the-counter (OTC) topical aerosol drug products and cosmetic products.

The FDA writes that the firm obtained the information and analytical data from different customers that the finished drug products manufactured with isobutane propellants were contaminated with benzene. Another customer informed the firm about possible benzene contamination in cosmetic products using dimethyl ether as the propellant. Despite this information and although the company uses dimethyl ether as a propellant in drug products, the internal investigation only focussed on the isobutane.

During the inspection, the FDA investigators collected samples of three of the company's products for laboratory testing. The results show the presence of benzene above 2 ppm.

The FDA considers the company's internal investigations as inadequate. Only reserve samples with higher propellant concentrations were selectively analyzed, but incoming propellants were not tested for benzene. So far, the root cause of the benzene contamination is not understood.

Furthermore, based on the company's response, it seems that the firm's procedure allows to blend non-conforming propellant with conforming propellant for the purpose of meeting specifications.

Beside the observations described above, the FDA also writes that the company failed to test topical drug products for critical microbiological attributes. Furthermore, incoming components were not adequately tested. Specifically, a limit test for diethylene glycol (DEG) and ethylene glycol (EG) on all lots of glycerin was not performed.

For further information, please see the Warning Letter to Accra-Pac, Inc. dba Voyant Beauty on the FDA's website.