FDA Warning Letter due to contaminated Hand Disinfectants

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.

Background

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:

• Written acceptance of responsibility for all products that are still on the market and whose expiration date has not yet passed.
• Indication of how quality assessment, including ongoing review of adverse events and customer complaints, will be maintained for medicinal products that remain in distribution
• A full reconciliation for all drugs that have not been recalled and are still on the market and have expired.
• A full reconciliation for all medicinal products received by the manufacturer as a result of its recall and for all products that remain in inventory.
• Submission of documentation for all medicinal products that have been disposed of, clearly showing how the product was inventoried, reconciled and disposed of.
• Submission of a detailed plan for the dissolution of the company that includes contact information and documentation supporting the dissolution and showing that the company has been deregistered with the FDA as a medicinal product manufacturer and that the equipment and property have been disposed of.

For further details please also see the FDA's Warning Letter to Sanit Technologies.