The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 5 July to a Baxter-owned manufacturing site following a nine-day inspection last July and August.
In two instances, the Claris Injectables Ahmedabad, India-based site acquired by Baxter (as part of a more than $600 million acquisition that closed in July 2017) was found to have invalidated out-of-specification (OOS) results without adequate investigation and scientific justification.
In both instances explained by FDA, the agency said the company “failed to expand your OOS investigations in a timely fashion to address potential manufacturing causes. When an investigation lacks conclusive evidence of laboratory error, a thorough investigation of potential manufacturing causes must be performed. Your acceptance of the passing results from testing a new set of samples based on an unproven hypothesis was insufficient to conclude the investigations.”
FDA also noted “a worrisome history of recalls due to substandard [redacted],” noting a recall of parenteral drug products in 2017 due to recurring complaints, as well as a 2010 Class I recall of all lots of four parenteral products due partially to non-sterility.
Baxter said in a statement to Focus
: "We are committed to fully implementing corrective and preventive actions to address FDA’s observations associated with the former Claris Injectables site.
"As a reminder, we assumed control of the Claris Injectables facility on July 27, 2017 (hours after the start of FDA’s inspection) and received the results of the FDA inspection within approximately one week of the acquisition’s close...The Claris warning letter is based on observations identified during the 2017 inspection of the Ahmedabad facility. While we responded to the 483 and have already implemented corrective actions, we are committed to completing the full integration of the Ahmedabad facility into our quality systems and any other items needed to fully address the Claris warning letter."
In addition to the Baxter warning letter, FDA on Tuesday also released a Form 483 sent to Mandal, India-based Hetero Drugs following a five-day inspection in February and March.
FDA found the firm’s quality unit failed to qualify and perform routine audits of multiple suppliers of computer software used for the GxP computerized systems.
Several QC personnel also could not explain their assigned functions and processes after repeated opportunities, FDA said.
Warning Letter Claris Injectables Limited 7/5/18
Form 483 for Hetero Drugs