FDA Slams Cadila Again With Warning Over Lack of Controls

The FDA has slapped India’s Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility.

During the inspections, the FDA found numerous deficiencies prompting the agency to issue further warnings. The FDA inspected the two Cadila manufacturing facilities in 2014. From Aug. 28 to Sept 5, inspectors evaluated operations at the Moraiya facility and from Dec. 1 to 6, they reviewed Ahmedabad operations.

At the Ahmedabad facility, the FDA told Cadila that its manufacturing process “is not in a state of control,” yet drugs are still being released to the market.

In September 2014, the company responded to an earlier FDA complaint that it would temporarily suspend making warfarin tablets until an investigation and corrective actions were taken. By November, the company resumed manufacturing the tablets. In June 2015, however, it acknowledged that additional lots had failed since production resumed.

The FDA said it continued to find inadequate investigations into the warfarin tablet failures, and the agency said the recurrence of product quality failures following the investigation indicates ineffective CAPA systems. “The recurrence of these failures is apparently due to inadequate identification of root causes and lack of action to resolve this manufacturing problem.”

At the Moraiya facility, the FDA identified what it said was the company’s failure to monitor processes that cause “variability in the quality” of APIs. It also found the company failed to identify root causes of failures and “processed the failed batches without scientific justification.”

Although Cadila acknowledged inadequate process controls, the FDA said its response was inadequate because it did not provide details, a root analysis or CAPA. The firm also failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data.

For example, the drugmaker had a file containing moisture content results for an API batch that was deleted and was not identified or reviewed. The company also failed to ensure proper recording of quality-related activities, and employees used “rough or unofficial notebooks” to document GMP activities.

In a conference call, Cadila’s Managing Director Pankaj Patel said the company is committed to “resolve these issues and revamp our quality systems” as a top priority.

Indian drugmakers continue to take a beating from FDA over GMP failures, with Dr. Reddy’s and Sun Pharmaceutical being the most recent recipients of agency warning letters.

Cadila has been repeatedly warned by the FDA about data integrity and impurity issues following inspections at its plants in India over the past two years.

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