Protective apparel is not worn as necessary to protect drug products from contamination,” the USFDA report said.
The USFDA was also concerned about a field alert report not submitted to it by Gland Pharma. The USFDA field alert programme is created to quickly identify drug products that pose potential safety threats. All drug manufacturers, whether innovators or generic drug makers, have to submit field alert reports if they find any significant problems with an approved drug within three days of a problem being identified.
Gland Pharma declined to respond to queries on whether the USFDA-identified issues have been resolved. On November 27, private equity firm KKR acquired a minority stake in the privately-held Gland Pharma for about $200 million or Rs 1,243.1 crore, according to the exchange rate on that day.
Mumbai-based Unichem Laboratories’ plant in Ghaziabad in Uttar Pradesh was inspected in June 2012 with four observations.
The regulator identified issues in documentary procedures and drug quality check in the company. “GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them,” the USFDA report said. “There were certain observations in June 2012 which duly taken care of by Unichem. The plant got re-certified by US FDA in October 2012,” Unichem vice-president K Subharaman said.
German company Fresenius Kabi Oncology’s Baddi facility in Himachal Pradesh got 11 citations from the USFDA after an inspection conducted in August 2012. The Gurgaon-based company is in the news for its attempts to delist from the Bombay Stock Exchange.