10-12 November 2021
As a result of problems with contamination of hand disinfectants - like with Burkholderia cepacia, a manufacturer in the US now received a Warning Letter from the FDA.
The company had brought batches of its hand disinfectant "Durisan Hand Sanitizer, Alcohol-Free" onto the market. This disinfectant, which is approved as an over-the-counter drug, did not meet the stipulated specifications, though. The affected batches had total aerobic bacterial counts (TAMC) and yeast/molds above specification from at least March through December 2020. In addition to this deviation, Burkholderia cepacia was detected by the company in batches of Hand Sanitizer Kidney, Hand Sanitizer and Sanitizer Wipes that were still released for distribution in April, July and December 2020. Since these products could also be applied to injured skin areas, the FDA considered the contamination to pose a serious risk to consumers. Complicating matters further, one of the largest purchasers was a school system that includes infant, toddler and preschool programs.
By releasing such kind of contaminated products, the company has not fulfilled its obligation not to release defective products for distribution. In addition, the quality department did also not take the necessary measures as could have been expected. No sufficient deviation investigations were started, and the company also failed to appropriately investigate the water system of the production, which was proven to be contaminated. It is especially important to note that the water system was already an issue in an inspection in 2019. The inadequate monitoring of the system had already been criticized then. Although appropriate changes and improvements were to be established with a new management, the FDA reports in its Warning Letter that the new management released and distributed at least 23 shipments with contaminated medicinal products containing high amounts of microorganisms.
Accordingly, the FDA has requested the following responses from the company to the allegations at the company, even as it notes that the company has closed the affected site as of June 30, 2021:
For further details please also see the FDA's Warning Letter to Sanit Technologies.