FDA WARNING_LETTER - baxter healthcare s.a. / - August 26, 2010

The FDA issued a Warning Letter to Baxter Healthcare Corporation following inspections of their Jayuya (July-August 2010) and Guayama (September 2010) pharmaceutical manufacturing facilities in Puerto Rico. The inspections revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), causing drug products to be adulterated under 21 U.S.C. § 351(a)(2)(B). Additionally, products from Jayuya were found to be misbranded (21 U.S.C. § 352(f)(1)), and both facilities failed to submit required NDA Field Alert Reports (FARs) (21 CFR § 314.81(b)(1)(i) and (ii), 21 U.S.C. § 355(k)).

Specific violations at Jayuya included inadequate investigations into discolored product and equipment malfunction, leading to the release of 17 at-risk lots and a delayed recall, a repeat observation from March 2008 (21 CFR § 211.192). The firm also failed to ensure container closure systems provided adequate protection, evidenced by 542 consumer complaints of leaks, bursts, and premature activation, and issues with foreign substances (21 CFR § 211.94(b)). Furthermore, a