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Baxter Puerto Rico Warning Letter, Recalls Follow FDA Findings of Problems with Complaint Investigations

Feb 6th, 2011

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FDA findings during a mid-2010 inspection at Baxter’s facility in Jayuya, Puerto Rico that appropriate action had not been taken to resolve problems reported in complaints and confirmed in the firm’s own internal investigations resulted in a multi-product recall the following month, a follow-up inspection of a companion facility in Puerto Rico two weeks after the recall, and an FDA warning letter covering both facilities three months later in late January.

Baxter is the third big pharma company whose compliance problems in Puerto Rico have drawn attention recently. Coincidentally, all three cases have centered around complaint investigations and the lack of decisive action to remove potentially implicated lots from the market.

[Editor’s Note: On the same day as the Baxter letter, FDA issued a warning letter to Wisconsin-based Scientific Protein Laboratories that also focused on complaint handling and recall decision making (IPQ “In the News” February 6).  SPL provided Baxter with the heparin API that was implicated in the oversulfated chondroitin sulphate (OSCS) contamination and the ensuing health crisis in 2008 (IPQ May/June 2008 Special Report). The SPL inspection referenced in the letter was part of FDA’s ongoing investigation of the crisis.]

McNeil’s Las Piedras, PR facility came under FDA inspection scrutiny in late 2009.  A warning letter followed in January 2010 highlighting the finding that the firm had not conducted “a timely, comprehensive investigation” of a series of complaints of odor in OTC products manufactured there.

The Las Piedras issues and those at McNeil’s facility in Fort Washington, PA, along with the associated recalls, drew Congressional inquiry beginning in May 2010.  Additional inspections and recalls followed later in the year (see IPQ “In the News” Jan. 19 for the latest coverage of the unfolding McNeil compliance story.)

GlaxoSmithKline’s operations in Cidra, PR also emerged into the limelight recently with the $750 million settlement this past fall of the government “whistleblower” suit against GSK involving GMP non-compliance at the facility between 2001 and 2005 (IPQ “In the News” Nov. 1, 2010)

The combination of the GSK and McNeil cases led the Congressional committee to extend its previous McNeil inquiry to an assessment of whether there has been sufficient GMP compliance oversight by the agency’s PR district over the last decade (IPQ “In the News” Nov. 14, 2010).

[More on the FDA concerns at Baxter’s Puerto Rican operations and how they relate to the agency’s current GMP enforcement priorities is provided for subscribers beginning on page 2. Non-subscribers can purchase the full story for $95 by contacting Wayne Rhodes ([email protected]).  For subscription information, click here.]

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