Fresenius Kabi Oncology Warned for Blended Batches and Tricking Inspectors
The FDA slammed Fresenius Kabi Oncology’s India plant for a multitude of quality issues ranging from blending batches to hiding manufacturing records from investigators.
The warning letter, posted online Tuesday, relates to a January 2013 inspection of Fresenius’ Kalyani, India, active pharmaceutical ingredient (API) manufacturing facility.
The agency charged in the July 2 warning letter that plant personnel misled investigators during the inspection. In one instance, an employee blatantly attempted to hide manufacturing-related records in his pocket from the FDA investigator, the letter reads.
Personnel also told investigators that all electronic raw data files were automatically stored on a central server inaccessible to quality control staff, and that no data was found on personal computers (PCs). However, later in the inspection, the agency found that “raw data was being stored in several folders on PCs,” according to the warning letter.
The FDA called for Fresenius to design computer systems with “appropriate security features and data audit trails.”
The agency was particularly dismayed when it found evidence that an API batch that failed to meet specifications was blended with a passing API batch. Fresenius responded that batch blending was not requested by management, which raised additional concerns.
“When your employees are able to decide that a failing API can be blended with a passing API batch to obtain a final passing result, this indicates that there is poor quality governance,” the FDA said.
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