Specifically, the warning letter – issued Oct. 15 – calls Cadila out for failing to “adequately investigate complaints and extend the investigations to other batches that may have been affected.”
One customer complained of an “unpleasant odor” from a specific batch, which an investigation concluded was the result of a “known impurity.” However, the Gujarat, India- based company failed to implement proposed corrective actions before closing the investigation in 2011.
A similar smelly complaint arose in 2012 and that compliant noted that a maximum unknown impurity exceeded the set specifications.
Cadila was also cited for its quality unit failing to exercise its responsibility to ensure the APIs manufactured are in compliance with established specifications for quality and purity. In addition, the company failed to prevent unauthorized access or changes to data or to provide adequate controls to prevent the omission of data.
“Your investigation related to the out-of-specification (OOS) result for the maximum unknown impurity for [one batch] concluded that the impurity had carried over from a raw material used in the API manufacturing process,” the FDA said. “This investigation did not address the failure of the quality unit to recognize this impurity OOS prior to release.”
The FDA seeks a response from Cadila detailing the chronology of the changes made to the API manufacturing process to control the process impurities since September 2011.
Cadila also was told to describe the controls implemented to prevent recurrence of levels exceeding in-house specification and to “explain your assurance that commercial batches of API within expiry meet your in-house specification.”
The agency also seeks information on the discrepancy found between the data provided during the inspection and the data provided in the company’s response to the initial Form 483.
“Include in your response information regarding the controls you have in place to prevent the use of raw material containing the undesirable impurity that was responsible for the [one] API batch failure. In addition, provide a chronology for the implementation of your revised raw material controls and a detailed assessment of batches still within expiry that were manufactured prior to the implementation of these controls,” the FDA says.
The company did not respond to a request for comment by press time.