Almost one year to the day Baxter acquired Claris Injectables, the United States Food and Drug Administration (FDA) sent a warning letter to Baxter in connection with the FDA’s inspection of the acquired facilities in Ahmedabad, India.
On July 27, 2017, the deal closed with Baxter purchasing Claris Injectables and on the same day, the FDA began an inspection of the Claris facilities in India. The inspection resulted in a Form-483, with several observations. On August 25, 2017, the company responded to the Form-483 and in a recent regulatory filing, noted that it had already implemented corrective actions to many of the issues the FDA raised in the warning letter, dated July 5, 2018.
The warning letter, however, notes that the FDA did review the August 25, 2017 response in detail and acknowledged receipt of additional correspondence. However, it still went on to note issues found in the inspection. One such violation was that Baxter “failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed,” which is a violation of 21 CFR 211.192.
In the warning letter, the FDA also took issue with the condition of the building, noting significant evidence of water damage in the facility, including warped ceiling panels, water puddles, and water stains. Water damage was also evident in skylights, vents, and ceilings above the finished product packaging area and in the personnel corridor outside the quality control laboratory. FDA also reported 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,” the warning letter reads. “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 FDA made several requests with respect to this issue, including the need for a comprehensive, independent review of your preventive maintenance program(s) for both facilities and equipment, and a CAPA plan to ensure its effectiveness. Your plan should include but not be limited to contingencies for expected seasonal fluctuations in rainfall.
FDA also requested a regulatory meeting with Baxter. “FDA is aware that Baxter acquired this facility the same day the inspection started. We request that you contact Tramara Dam … within five days of receipt of this letter to schedule a regulatory meeting. Please come prepared to discuss Baxter’s comprehensive remediation plans for this facility.” 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 is just an estimate.