In 2013, U.K. and European regulators banned most products from a Wockhardt plant in India that was found faking data, but the U.K. allowed it to continue shipping a few that were required for essential medicines. This week, the U.K. stiffened the action to include all active ingredients from Wockhardt's plant in Chikalthana, a facility the FDA has also banned from shipping to the U.S.
In an update to its initial ruling the Medicines and Healthcare Products Regulatory Agency (MHRA) said: "The initial statement of serious noncompliance permitted continued supply of critical APIs. Following a company decision to cease supply of API to the EU market, this statement of noncompliance was updated to cover all active substances in January 2015. Reinspection by an EU national; competent authority will be required prior to gaining approval to supply the EU market in future."
Like the FDA, U.K. and European regulators found significant lapses at the Wockhardt operation, which manufactures both solid and sterile products. The U.K. said records indicating proper procedures had been followed had the signatures of employees who were not even at the plant. The agency also cited it for contamination concerns like products being stored near asbestos sealed areas, and poor sanitation that could not assure drugs were not being contaminated. The agency found additional problems during a reinspection in November 2013, it said this week.
Both the U.S. and U.K. that year had also banned products from another Wockhardt operation, this one in Waluj. The MHRA had insisted Wockhardt recall 16 drugs when the Waluj plant was cited. An FDA warning letter for that plant said quality-assurance personnel tried to hide records of batch failures and to destroy samples that inspectors wanted to examine. Inspectors also found leaking toilets and a puddle of urine in a bathroom near a sterile manufacturing area. The Indian drugmaker has had its financials devastated by the regulatory actions, reporting two quarters in which profits were down more than 90%.
- find the filing here