UK Regulator Cites Another Wockhardt Plant For Problems

For the second time in four months, UK’s Medicines and Healthcare Products Regulatory Agency has tagged Wockhardt for manufacturing problems at a key facility. The latest infraction led the regulator to withdraw certification for the same facility that prompted the FDA to issue a warning letter last July after employees played hide-and-seek with requested documents, among other things (back story). "We have issued a statement of non-compliance against Wockhardt’s site in Chikalthana, India after recent inspections identified a number of manufacturing issues that breach Good Manufacturing Practice (GMP) guidelines,” an MHRA spokesman writes us. The drugmaker, however, can continue exporting some critical drugs to the UK to avoid shortages of essential medicines. The move by the MHRA underscores the heightened scrutiny being placed on drugmakers in India. The FDA, for instance, is reportedly planning to follow the same system of facility inspections in India that is followed in the US and other developed countries. Toward that end, the agency has expanded its inspection team from 12 to 19 people, and opened two more offices (see this). Concerns have mounted in the wake of the scandal involving Ranbaxy Laboratories, which recently agreed to pay $500 million to the US Department of Justice to settle criminal and civil charges associated quality control problems at its plants in India. Violations included fabricating in-house test data and concealing these activities from FD...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs