FDA EIR - Baxter Healthcare Corporation - November 20, 2018

Baxter Healthcare Corporation's Cleveland, MS facility underwent an FDA inspection from November 14-20, 2018. This surveillance inspection, focusing on sterile pharmaceutical manufacturing under the Drug Processing Inspection Program (aligned with 21 CFR 211.100(b) for production and process control procedures), identified several critical issues. The main violations, documented on an FDA-483, centered on non-adherence to written production and process control procedures.

Key issues included the recurrence of equipment validation deviations (e.g., temperature limit failures for a new system) between operational and performance qualification phases, which was attributed to employee error in software backup. Furthermore, corrective and preventative actions (CAPA) stemming from these validation deviations were inadequately documented, with the firm initially deeming further action unnecessary, a stance challenged by the inspector. The inspection also found insufficient documentation of operational qualification acceptance test results for a laboratory system and a packing line's labeling inspection station, with only "Pass" or "Fail" noted instead of detailed observations or objective evidence.

In response, Baxter Healthcare committed to amending protocols for the laboratory system to include objective evidence for alarm message re-verification. The packing line inspection system was scheduled for replacement, with its new validation governed by updated procedures requiring photographic or descriptive documentation of test results. Employee training on these updated procedures was also completed. The company provided a written response to the FDA's observations.