FDA EIR - BlendHouse LLC - February 17, 2023

The FDA conducted an inspection of BlendHouse LLC in Reading, PA, from December 21, 2022, to February 17, 2023. The inspection revealed significant deficiencies in the company's manufacturing processes for infant formula, operating under the regulatory framework for infant formula safety. Key violations, documented in a Form FDA 483, included the failure to establish adequate process controls to prevent microbial adulteration of infant formula and its processing environment. Additionally, equipment design was not consistently appropriate for its intended function.

The inspection highlighted pervasive issues with environmental monitoring, including repeated detections of Cronobacter sakazakii in manufacturing areas. These instances were linked to insufficient cleaning frequencies, ineffective sanitizers, improper cleaning procedures, and inadequately trained personnel. Two water leak events were identified as sources of environmental contamination. Record-keeping also presented problems, with frequent data alterations and delays in quality control reviews. A prior recall related to Cronobacter was noted, and subsequent production lots were found positive for pathogens or out-of-specification for microbial counts, or contained foreign material. The company was required to submit a written response to the Form FDA 483 observations, outlining corrective actions. Management acknowledged the identified issues and committed to addressing them, with some corrective actions, such as floor replacement and increased cleaning, already initiated.