second time Wockhardt has seen adverse action from the UK regulator. In July, the UKMHRA initiated a precautionary recall of 16 prescription medicines owing to manufacturing deficiencies identified at Wockhardt’s Waluj site.
The recall had followed an inspection in March which noted poor cleaning practices and defects in building ventilation systems and evidence of forged documents relating to staff training records.
Wockhardt, which has seven production sites in India, has also been caught in the crosshairs of the US Food and Drug Administration. The US health regulator placed Wockhardt’s Waluj facility under an “import alert” preventing entry of products manufactured at the plant in the country.
It had also issued a Form 483 to Wockhardt after an inspection conducted jointly with the UKMHRA in July. The form lists certain certain deficiencies observed by the investigator during inspection of the unit.
Wockhardt anticipated the Waluj ban to adversely impact its revenue to the tune of $100 million on an annual basis. In August, the company confirmed that it has appointed a third-party consultant, US based-Lachman GMP Consultant Inc USA, to review and advise on the GMP shortfalls of both units.