Pan Drugs received the Warning Letter this month, with the US Food and Drug Administration (FDA) citing a number of deviations from GMP standards during an inspection of the Nandesari, Vadodara facility in July 2014.
The agency said the firm failed to maintain, repair, and keep clean its API manufacturing units, with the investigators observing “holes in the walls and roof which allowed pigeons access near production equipment” and “gaps and holes in outside walls for piping and air ducts which allow contaminants to enter the building.”
Pan Drugs’ failures in maintaining its API making equipment were also observed: “Our investigator observed rust, dirt, lubrication leaks, and exposed insulation material on and around open drug manufacturing equipment,” the Letter says.
The FDA states that Pan Drugs continued to supply the Indian market after recognising the facility and equipment were in disrepair and not compliant with cGMP.
However, according to Pan's technical director Prem Goel, manufacturing for both domestic and international markets was ceased after an FDA Form 483 was issued in July 2014.
“We have given the commitment to stop all production while we renovate the facility,” he told in-Pharmatechnologist.com. “We are completely knocking down the two [affected manufacturing] blocks and reconstructing them.”
While the FDA has questioned the firm’s commitment to remediation, saying the plant was also under renovation during a previous inspection in May 2011, Goel told us construction of the new suites will be completed by November, with the firm ready to invite the FDA back for a reinspection from January 2016.
He also said the firm only exports one API to the US – guaifenesin used in expectorant OTC drugs – and volumes were only around 25 metric tons per year.
The FDA disputes this in its letter, claiming the company had been “manufacturing and shipping significant quantities of other APIs to the United States,” after reviewing US import documentation.
We contacted the FDA for further comment: "The FDA’s focus remains on the US market, and the language in the warning letter speaks for itself," a spokesman said. "We have no further comment on the response from Pan Drugs."