Regulatory Focus™ > News Articles > Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections

Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections

Posted 08 August 2016 | By

Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections

Pfizer and Wockhardt are struggling to keep pace with pharmaceutical good manufacturing practice (GMP) regulations as two recent inspections of their manufacturing sites in India resulted in a US ban for Wockhardt and a temporary suspension of the Pfizer site.

For Pfizer, the inspection of its Chennai-based site, acquired as part of its $16 billion purchase of Hospira, was a joint effort for officials from four regulators: the US Food and Drug Administration (FDA), UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Australia’s Therapeutic Goods Administration (TGA) and Health Canada.

FDA spokesman Kris Baumgartner told Focus: "FDA frequently conducts joint inspections with its regulatory partners in the international arena and there are a number of reasons that trigger this collaboration. These activities serve to build confidence in other regulatory systems, promote a better understanding of the systems within these regulatory bodies, and also promote information sharing between regulators that ‎have common objectives."

The cooperative inspection, which led to Pfizer’s decision to temporarily suspend production at the Irungattukottai site, follows an FDA warning letter for the site in May 2013 and a Form 483 with 23 observations from January 2014.

“Pfizer has formally responded to the inspection findings issued following the recent inspection of the legacy Hospira Irungattukottai, India site. The site is implementing actions to address the findings,” Pfizer spokeswoman Kim Bencker told Focus. “Patient safety is of utmost importance to Pfizer, and Pfizer is committed to ensuring the safety and quality of our medicines.” 

Wockhardt Import Alert

Meanwhile, Wockhardt’s Ankleshwar-based manufacturing site was added to FDA’s import alert list on Friday. The inclusion of a manufacturing site to the list means the site is not operating in conformity with GMPs, according to FDA.

This is Wockhardt’s third manufacturing site to be added to the list since 2013, with the other two coming from Aurangabad.

A March 2013 inspection by FDA resulted in an import alert for products manufactured at the company's Waluj, Aurangabad facility, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a massive recall for products manufactured at the same facility. Highlights from that warning letter included the facility’s manufacture of a product intended for US export, but the company did not tell FDA about its existence until investigators identified it.

An FDA investigator also pressed employees for access to quality control data and raw testing documentation for a tablet product manufactured at the facility "no less than six times," but the data was only provided to FDA during the close-out meeting several days later without any explanation.

Similar to other violations reported by FDA across India in Form 483s, FDA found at the Waluj site "approximately 75" unofficial batch records "torn in half in a waste area" confirming that many batches did not meet established visual inspection criteria. Those batches reportedly included "black particles, fibers, glass particles, sealing defects and volume variations."

Thirty-two other pharmaceutical companies in India have sites listed on FDA’s import alert list.

Editor's Note: This article was updated on 8/9/16 to include FDA's comment on the joint inspection.


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