FDA EIR - Pfanstiehl, Inc - October 05, 2017

An FDA surveillance inspection of Pfanstiehl, Inc., a manufacturer of Active Pharmaceutical Ingredients and excipients located in Waukegan, IL, was conducted from October 3-5, 2017. The inspection, performed under Compliance Program 7356.002F, focused on the company's Quality, Materials, and Laboratory Control systems.

Significantly, no formal FDA-483 Inspectional Observations were issued during this inspection, and no verbal discussion items were presented at the close-out meeting. This indicates a generally compliant status, with previous concerns from a 2016 inspection regarding documentation of investigations for monitoring limit excursions and internal audits of electronic data systems having been adequately addressed.

However, the inspector raised several points for discussion. Concerns were noted within the Materials system regarding the supplier qualification procedure, specifically its lack of provisions for for-cause auditing or validation of supplier Certificates of Analysis. Management expressed willingness to consider improvements. In the Laboratory Control system, the appropriateness of Administrator role assignments for certain personnel in analytical software was discussed. Furthermore, an issue of analytical method variability leading to out-of-specification results for an HPLC assay of a specific stability batch was identified, though repeat testing met specifications. Pfanstiehl, as a contract manufacturer, stated revalidation required client consent. These points were discussed but not cited as formal violations, meaning no regulatory actions were immediately required from the firm.