Sandoz gets FDA rap over documentation at plants

A warning issued in October following inspections at firm's plants near Mumbai is now up on the regulator's website

The US Food and Drugs Administration (FDA) has issued a warning letter to Sandoz, the generic drug division of Novartis, over the lack of proper production and control records as well as written procedures to prevent contamination of products at its manufacturing units near Mumbai.

The US drug regulator has released the letter, issued in October, on its website. The warning was issued following regulatory inspections at Sandoz’s plants at Kalwe and Turbhe near Mumbai.

In its observation regarding the Kalwe facility, FDA said the company failed to prepare batch production and control records for each batch of drugs that includes documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch.

In an e-mailed response, a Sandoz spokesperson said: “The topics in the warning letter are largely related to good documentation practices at the Kalwe site and aseptic processes at the Turbhe site. The warning letter does not contain any new concerns versus the original observations issued following the inspection in August 2014, which Sandoz has been addressing since. Sandoz takes health authority inspection outcomes seriously and will continue to work closely with the FDA to ensure all observations are resolved to the agency's full satisfaction.”

“Two uncontrolled excel spreadsheets were used to record discrepancies and certain in-process drug quality data. This data was initially missing in the batch manufacturing record. Your firm later entered this data into batch records and backdated them,” FDA states in its warning letter. It also found that the company had not developed controls in computer system. Such controls are necessary to ensure only authorised persons make changes in production and control records. FDA said the company also failed to thoroughly investigate any unexplained discrepancy or failure of a batch.

At the Turbhe plant, FDA found the company to have failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products.