FDA WARNING_LETTER - Baxter Healthcare Corporation - August 26, 2010

An FDA inspection from July to August 2010 at Baxter Healthcare Corporation's Jayuya, Puerto Rico facility, and a subsequent inspection in September 2010 at its Guayama, Puerto Rico facility, revealed significant Current Good Manufacturing Practice (CGMP) violations, causing drug products to be adulterated under 21 U.S.C. § 351(a)(2)(B). Additionally, products were found to be misbranded under 21 U.S.C. § 352(f)(1), and the firm failed to submit NDA Field Alert Reports (FARs) as required by 21 C.F.R. § 314.81(b)(1)(i) and (ii). Specific violations at Jayuya included a repeat observation of failing to thoroughly investigate batch failures and out-of-specification results (21 C.F.R. § 211.192), such as discolored product and potential cross-contamination, and relying on healthcare professionals for quality control. The firm also failed to ensure its container closure system provided adequate protection (21 C.F.R. § 211.94(b)), evidenced by numerous product defects like leaks and foreign substances. Furthermore, the distribution of an unapproved color chart for product use constituted misbranding. Both Jayuya and Guayama facilities failed to submit FARs within three working days for product defects, including discolored amino acid injections and particulate matter in Suprane. Baxter's responses were deemed insufficient. The FDA requires prompt corrective actions within fifteen working days, with potential legal actions, impact on federal contracts, and withholding of approvals for export certificates or drug applications if violations are not corrected.