FDA objects to Cross-Contamination risks from shared Equipment

During an inspection of a US OTC manufacturer in June 2026, the US FDA identified a significant risk of cross-contamination between pharmaceutical and non-pharmaceutical production and issued a Warning Letter.

The FDA criticises the manufacturer for failing to establish adequate procedures for cleaning and maintaining manufacturing equipment. In particular, the FDA considers the cleaning validation to be insufficient to demonstrate that cross-contamination between OTC medicines and non-pharmaceutical products does not occur. The OTC drugs were manufactured on non-dedicated equipment that was also used for the production of non-pharmaceutical products.

In the FDA's opinion, if residues are not adequately removed during cleaning, there is a significant risk that subsequently manufactured drugs will be contaminated. According to the FDA, the simultaneous use of the same equipment for pharmaceutical and non-pharmaceutical products is unacceptable from a GMP perspective, as this poses an increased risk of cross-contamination.

The manufacturer announced that it would develop and implement a site-wide cleaning validation master plan, including the identification of relevant equipment, analytical methods and acceptance criteria, as well as the definition of worst-case products and surfaces that are difficult to clean. However, the FDA considers this response to be insufficient. The FDA lacks a risk assessment for drugs already manufactured on non-dedicated equipment that may be potentially affected by inadequate cleaning. In addition, the planned timeframe for completing cleaning validation is not until August 2026, with no interim measures described to ensure adequate cleaning of non-dedicated equipment until then.

Overall, the FDA assesses the manufacturer's existing cleaning and documentation system as inadequate to ensure product quality and patient safety. The FDA is calling for a fundamental overhaul of the cleaning programme, including a retrospective assessment of all affected products, clearly defined CAPA measures, improved cleaning validation under worst-case conditions, and appropriate documentation processes to effectively eliminate cross-contamination risks in the future.

Please also see the FDA website for the detailed Warning Letter to the US manufacturer.