Regulatory Focus™ > News Articles > Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

Posted 28 April 2016 | By Zachary Brennan 

Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator.

This week, the US Food and Drug Administration (FDA) released its warning letter for the company following an eight-day inspection in March 2015. The three major issues uncovered by FDA included the company’s failure to record or investigate quality-related customer complaints, its failure to review and investigate production deviations and the failure of its computerized systems to have sufficient controls to prevent unauthorized access or changes to manufacturing data.

Polydrug says on its website that it manufactures Chlorobutanol Hemihydrate for Mexican, Russian and Ukrainian markets, fluconazole (which is under FDA investigation for other reasons) for Canadian, Chines, Korean, Russian and Singapore markets, losartan potassium for Canadian and Korean markets, and metoprolol succinate and metoprolol tartrate for the Russian market.

The company told Focus that by the time the warning letter was published by FDA, Polydrug had already requested that the agency re-inspect the site. "Polydrug is working with FDA to resolve the issues raised and comply to all the recommendations made by the agency," a spokesman said via email.

The warning letter comes as FDA banned all products manufactured at the company’s site from entering the US in September 2015, and as Slovenian inspectors uncovered serious issues in June 2015 that led Health Canada to issue a voluntary quarantine for all APIs sourced from the company.

Polydrug is the latest in a growing list of Indian pharmaceutical, contract research or API companies to receive an FDA warning letter related to data integrity issues.

Warning Letter Details

Among the most egregious findings, an FDA inspector discovered a torn sheet of paper titled “Product Quality Complaints” on the floor of the company’s warehouse and when compared to the firm’s official compliant log, found that only two of the 17 customer complaints on the torn sheet were recorded in the official log.

“Although the 17 complaints in the unofficial log were not from US customers, your firm uses shared equipment, personnel, and materials to manufacture products for multiple markets, including the United States,” FDA said. “Your firm’s poor complaint handling practices and your inability to prevent and detect product quality defects, such as filth, indicate significant lapses in your firm’s quality system.”

In the same inspection, an FDA investigator also found another torn page from a batch production record in the trash with discrepancies between the discarded page and the complete batch production record.

In addition, FDA found that Polydrug’s computer system for entering test results and storing certificates of analysis (CoA) documenting whether a drug meets quality specifications, “does not have sufficient controls to prevent unauthorized changes to a CoA after quality unit approval.”

The agency also took issue with all of the company’s responses to the deficiencies cited and is calling for:

  • A comprehensive investigation into the extent of the inaccuracies in data, records and reporting
  • A current risk assessment of the potential effects of the observed failures on the quality of drugs. 
  • A management strategy that includes the details of a global corrective action and preventive action plan. 

Update: Article updated 5/2/16 with comment from Polydrug.

Warning Letter


Categories: Regulatory News

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