US FDA calls CTX Lifesciences' plant remediation plan inadequate
The US regulator made the request in a warning letter this week, explaining that CTX’s response to problems flagged by inspectors who visited its active pharmaceutical ingredient (API) site in Surat, Gujarat last year is insufficient.
In particular, the US Food and Drug Administration (FDA) asked CTX how it will address deficiencies in its cleaning procedures to prevent potential carry-over contamination in its API production areas.
At the time of the inspection, the FDA raised concerns that CTX had released several API batches without conducting mandatory
Quality lab
The FDA also said CTX’s plan to bring its quality unit into line with current Good manufacturing practice (cGMP) requirements is inadequate.
At the time of the inspection, the FDA team raised concerns that CTX had released several API batches without conducting mandatory ultraviolet (UV) spectrometry testing.
In the letter the agency said CTX’s contention “the quality of the released batches was adequate because other required release tests were passed” is inadequate and called on the firm to provide details of all affected batches.
Retrospective analysis
The US regulator also said CTX needs to investigate production deviations rather than simply attribute them to mechanical breakdowns or operated delays.
Finally, the agency said that although CTX has validated a method for assessing the water content of API batches, the firm has not applied the method to products previously released.
