FDA EIR - Eurofins PHAST GmbH - July 17, 2018

An FDA surveillance inspection of PHAST GmbH, a contract testing facility in Homburg, Germany, was conducted from July 16-17, 2018. The inspection, performed under the drug manufacturing regulatory framework, focused on the firm's Quality and Laboratory Control Systems, as it provides services for various U.S.-marketed drug dosage forms. Notably, this inspection concluded without issuing a Form FDA 483 (Inspectional Observations), indicating no official regulatory violations were documented. However, two significant issues were verbally discussed with management. First, the firm's Out-of-Specification (OOS) procedure requires strengthening, as it currently lacks a defined limit for retesting when laboratory errors are identified, raising concerns about 'testing into compliance.' Second, improvements are needed in testing documentation; a deviation from an approved High-Performance Liquid Chromatography (HPLC) method was not referenced in the relevant write-up, and a required column equilibration step was not documented. PHAST GmbH was reminded of its ongoing responsibility to detect and correct any manufacturing practice deviations, irrespective of formal inspection findings. The firm was recently acquired by Eurofins in 2018.