According to the warning letter published earlier this month, the US Food and Drug Administration (FDA) observed a number of attempts to conceal data manipulation during an inspection in January at the Kalyani, India, API facility.
“Misleading information related to the practices of ‘demo’ and ‘trial’ testing” was provided to the investigator, the letter said, adding that “QC personnel refused to provide requested information regarding observed sample testing practices.”
Fresenius spokesperson Matthias Link told in-Pharmatechnologist.com: “Several of those GMP non-conformities were a result of employees ignoring manufacturing and documentation standards and, thus, clearly violating our corporate code of conduct.
“This is clearly a non-recurring one-time event related to employee misconduct,” Link told in-Pharmatechnologist.com. “As an immediate measure, the entire plant management and all employees involved have been replaced.”
Other examples of violations cited in the letter included an employee being seen by inspectors trying to hide manufacturing related records in his pocket, and the observation of foreign material in an API batch which - following a quick area clean up - was palmed off to inspectors as “a reflection of the light.”
API Procurement and Production Restart
The facility manufactures some APIs (active pharmaceutical ingredients) used in the production of Fresenius’ cancer drugs, however, the plant is not the firm's only source, Link said.
“We have been working on different solutions such as the procurement of APIs from other sources and have, thus, been able to avoid major supply interruption.”
Furthermore, he added, the warning letter listed no additional findings to the 483 the facility received after the inspection, thus remediation of the issues raised has been ongoing since January when production was put on hold as a precautionary measure.
“Based on a detailed remediation action plan submitted to the FDA, the restart of the facility is currently already underway.”
This includes, he continued, “audits by external parties [which] are performed on a bi-monthly basis and are supplemented by additional GAP assessments for specific topics,” as part of the firm’s quality control protocol and in close coordination with FDA.