UK MHRA Orders Wockhardt Recall In Light of India Plant Problems
The recall follows a week after the UK drug watchdog issued the Indian manufacturer with a statement of non-compliance for the facility, at which oral solid dosage for drugs are produced.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) said that it issued today’s recall because “the medicines have not been manufactured to the right regulatory standards.”
Gerald Heddell, the MHRA’s Director of Inspection, Enforcement and Standards, said: “This is a precautionary recall. People can be reassured that there is no evidence that medicines made by Wockhardt are defective so it’s important people continue to take their medicines as prescribed.
The agency explained that deficiencies identified during the routine inspection in March included a low risk of cross-contamination because of “poor cleaning practices and defects in building fabric and the ventilation systems at the site.”
It also said that: “There was also evidence of forged documents relating to staff training records that had been rewritten. The MHRA is working with Wockhardt and other international regulators to resolve these issues.”
Earlier this week Sirjiwan Singh, MD at Wockhardt UK, told in-Pharmatechnologist.com he is confident the problems at the facility – which supplies the firm’ UK and US subsidiaries – will be rectified within three months with a re-audit by the MHRA scheduled for September.
“As far as this goes, we have answered to all the queries raised by the MHRA in the statement,” he said. “No critical observations were made [by the MHRA], only major observations of which we have addressed.”