Regulatory Focus™ > News Articles > FDA Warning Letter Details Serious Violations by another Indian API Manufacturer

FDA Warning Letter Details Serious Violations by another Indian API Manufacturer

Posted 15 September 2015 | By Zachary Brennan 

FDA Warning Letter Details Serious Violations by another Indian API Manufacturer

The US Food and Drug Administration (FDA) on Tuesday released another Warning Letter for an Active Pharmaceutical Ingredient (API) and drug manufacturer in India with a series of severe findings.

The most recent letter sent to Gujarat, India-based Pan Drugs, which is already barred from supplying drugs and APIs to the US, follows the identification of more Current Good Manufacturing Practices (CGMP) violations by FDA inspectors, including data integrity issues, as well as some questionable comments made by the company to the agency.

Background

FDA has been in the midst of a crackdown against deficient manufacturing practices abroad, particularly in India, where inspectors have alleged serious data fraud over the past few years.

Since 2013, FDA has issued at least eight Warning Letters to Indian companies alleging improper data controls. FDA also sent out to Indian firms at least 50 Form 483s, which are typically the precursor to Warning Letters.

On Monday, FDA also banned Indian drugmaker Polydrug Laboratories from importing any of its APIs to the US. The company was previously warned by Health Canada and European inspectors.

European regulators have taken similar action, and most recently pulled from the market at least 700 drugs over concerns of data manipulation by an Indian contract research company. Between 2011 and today, Polydrug's site is the 44th manufacturing facility that is currently barred from exporting to the US.

Pan Drugs

This latest Warning Letter primarily addresses issues related to the company's failure to maintain, repair and clean buildings used to manufacture APIs.

More specifically, an FDA investigator "observed holes in the walls and roof which allowed pigeons access near production equipment in multiple manufacturing areas." The investigator also found "rust, dirt, lubrication leaks, and exposed insulation material on and around open drug manufacturing equipment."

And when the FDA called out the company for continuing to manufacture product intended for the US, even after it recognized that its facility and equipment were in disrepair, the company told the agency that it  “decided to divert the referred batches” to the domestic (India) market. 

Meanwhile, during a July 2014 inspection, Pan said it produces only one API for the US market, but FDA said that after reviewing import entries, it found that Pan has been manufacturing and shipping "significant quantities" of other APIs to the US. "The import documents detail shipments directly from your facility both before and after the inspection," FDA says, asking for further information on this disparity.

Some of Pan's testing data also failed to conform with established specifications and standards, and like many manufacturers before it, FDA recommended that the company engage a third-party consultant with appropriate CGMP expertise to "comprehensively assess your firm’s entire operation, including facility conditions, procedures, processes, laboratory controls, and quality management systems."

“Until we receive adequate confirmation that you have made global corrections, we will not schedule a follow-up FDA inspection and your firm will remain on Import Alert," FDA said.

The company was also hit with a warning letter back in 2012 for failing to register its facilities in 2011 and 2012, though it continued to manufacture, prepare, propagate, compound, or process drugs that were being imported or offered for import into the US over those years.

Warning Letter for Pan Drugs


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