FDA EIR - BlendHouse LLC - June 09, 2022

An FDA inspection of BlendHouse, a manufacturer of infant formula located in Reading, PA, was conducted from May 23 to June 9, 2022. The surveillance inspection was performed under regulatory frameworks for Infant Formula and Food cGMP, including 21 CFR 106 and 31 CFR 107. While no official Form FDA 483 was issued, the inspection revealed several areas needing improvement, identified as "discussion items" with management. Key issues included the firm's non-adherence to its "Facility Water Leak Control" Standard Operating Procedure (SOP). Following a roof leak, required environmental swabs were not conducted within an appropriate timeframe (13 days between swabs, instead of the implied 4 consecutive days), and the pathogen testing scope for water events differed from their standard environmental monitoring program. Additionally, production records exhibited significant deficiencies. These included illegible entries, numerous cross-outs and corrections for incorrect lot codes, job numbers, and weights. Forms often lacked specified acceptable ranges for testing parameters, and recorded values were sometimes "rounded" to fit specifications, rather than consistently matching target decimal points. The firm also initially failed to consistently document a critical dryer operation time frame as required by their "Infant Formula Operation" SOP. As a result of these discussions, BlendHouse committed to reviewing and updating relevant SOPs, retraining employees on proper record-keeping, revising QA testing forms to ensure clarity and consistency, and incorporating the previously overlooked dryer operation documentation into batch records to ensure full compliance.