FDA warning for Sandoz after data and training issues at Indian plants

25-Nov-2015 - Last updated on 25-Nov-2015 at 15:35 GMT

Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.

Novartis announced in its quarterly results earlier this month that two facilities run by its subsidiary Sandoz in Mumbai received a Warning Letter from the US Food and Drug Administration (FDA).

The warning letter published yesterday identified a number of violations of cGMP at Sandoz’s Kalwe finished dosage manufacturing failed, including failures in preparing and controlling batch and equipment maintenance records.

But the Agency also pulled up the firm on its education and training records: “While a significant number of your contract employees do not speak English, you only provided English training materials to these employees,” while the employee contracted to carry out training was unable to explain the relevant material.

“We also found an employee’s failing equipment qualification training assessment form in the trash, yet that employee’s official file showed passing results,” the letter states.

Sandoz spokesman Bernhard Schneider told in-Pharmatechnologist.com production at both Kalwe and the nearby API plant Turbhe “is not affected and no supply disruptions are expected” following the warning.

“We have been working diligently on corrective actions at the Kalwe and Turbhe sites in India since the inspections last year, and continue to keep the US FDA updated on our actions,” he said. “We will work closely with the Agency to ensure all issues outlined in the Warning Letter are resolved to the Agency’s full satisfaction.”

While he could not speculate on the Agency’s timing, he told us there had not been any indication that the Agency will take any further actions.

Turbhe API plant

The Turbhe site makes the APIs, antibiotics and sterile injectables but has been earmarked for closure by the end of 2016 as part of a manufacturing refocus in India.

While the FDA is aware of the plan to shutter or divest the site, it noted a number of cGMP violations relating to aseptic process controls due to the similarity to violations at a Sandoz facility in Quebec, Canada, which resulted in a Warning Letter in 2011.

These included the failure to establish protocols to avoid microbiological contamination and failures in monitoring environmental conditions at the site.