A full year after acquiring Claris Injectables, FDA has hit Baxter with a warning letter in connection with the agency’s inspection of the acquired facilities in Ahmedabad, India.
Baxter added Claris to the pharmaceuticals side of its business last year and the $625 million deal is expected to provide a foundational growth platform for the company.
FDA began an inspection of the Claris facilities the same day the deal closed, July 27, 2017, which resulted in a Form-483 noting several observations. The company responded to the 483 on Aug. 25 and said in a recent regulatory filing with the Securities and Exchange Commission that it has already implemented corrective actions to many of the issues FDA raised in its warning letter, which is dated July 5, 2018.
Among other violations the agency noted, FDA investigators reported significant evidence of water damage in the facility, including warped ceiling panels, water puddles, and water stains. Water damage was evident in skylights, vents, and ceilings above the finished product packaging area and in the personnel corridor outside the quality control laboratory.
FDA said there also were ceiling panels in certain areas that were not sealed, allowing ingress of air from the buildings plenum into post-sterilization areas.
“It is essential that your plant management maintain the facility in a good state of repair to ensure ongoing suitability for drug manufacturing,” FDA said in the warning letter. “In your response, you attribute the water damage to monsoon rains that fell in the days prior to the inspection. However, the observed staining, rusting pipes, and warping of walls and ceiling panels appeared to indicate the presence of longer-term water and humidity problems in some cases.”
The agency also said the company’s previous response focused on water leak repairs and some enhanced preventive measures. The response does not, however, adequately address production management’s daily responsibilities to promptly address facility damage and the potential for fungal contamination to persist in the facility due to moisture problems.
The warning letter does not change Baxter’s long-term financial guidance, the company noted, because it did not include any 2018 revenue for new Claris product launches in the United States in its financial guidance for the year.
Baxter also said it is evaluating other potential locations, including contract manufacturing organizations, to support the production of new products for U.S. distribution to mitigate the risk of any delay in its ability to fully remediate the Claris facilities to FDA’s satisfaction beyond the first half of 2020. These could also use these other locations to support the production of any pending product approvals.
FDA requested a regulatory meeting with Baxter. The company said it expects the meeting to occur this year, followed by a re-inspection of the Claris facility before the second half of 2019, although such timing cannot be guaranteed.
FDA noted that the Claris facility had been cited for similar violations in a November 2010 warning letter, although the agency did acknowledge in its current letter that Baxter acquired the facility the same day as the most recent inspection began.