Baxter Healthcare Corporation – FDA 483, Jan 23, 2014

This FDA Form 483 documents observations from an inspection, citing deficiencies in the quality control unit and manufacturing processes. The facility manufactures drug products, including 0.9% Sodium Chloride Irrigation and Sterile Water for Irrigation, contained in plastic pour bottles.

A key observation is that the quality control unit lacks the responsibility and authority to reject all drug products. Specifically, the firm's QA department approved and released five finished drug product lots (b)(4) - 0.9% Sodium Chloride Irrigation; (b)(4) - Veterinary 0.9% Sodium Chloride Irrigation; (b)(4) - Sterile Water for Irrigation; (b)(4) - Sterile Water for Irrigation; and (b)(4) - 0.9% Sodium Chloride Irrigation. These lots were in plastic pour bottles made from plastic (b)(4) from supplier (b)(4). The firm knew this lot of (b)(4) was contaminated with (b)(4) by its supplier before manufacturing and filling these bottles.

Additionally, control procedures are not established to validate manufacturing processes. An (b)(4) metal detector was installed on 11/02/2012 on the (b)(4) supply line to address (b)(4) contamination from the plastic (b)(4) supplier. This (b)(4) is used for manufacturing plastic pour bottles/caps. On 06/19/2013, a