The US FDA has sent Wockhardt a warning letter for its manufacturing plant in Waluj, India just days after UK authorities issued the site with a certificate of non-compliance.
In May, following an inspection at the manufacturing facility by the US Food and Drug Administration (FDA), the regulators imposed an import alert , stopping all drugs produced at Wockhardt's Waluj facility in Aurungabad, India from entering the US.
Now Wockhardt has announced it has “received a ‘warning letter’, which lists the observations made during the inspection” in a filing made to the National Stock Exchange of India (NSE) on Saturday. The firm's share price dropped 10 percent when the market opened this morning.
In the filing the firm “continues to cooperate with FDA to resolve the issues at the earliest” instance. This was confirmed by Managing Director of Wockhardt UK, Sirjiwan Singh, who told in-Pharmatechnologist.com that: "Wockhardt has started all the corrective actions already and is responding to all issues brought up by the FDA.”
The Waluj site houses two facilities – one that makes sterile injectables for the US market and the other that makes solid dosage drugs, mostly not for the US.
According to Wockhardt’s Chairman Habil Khorakiwala the firm invited the FDA to inspect the facilities in order to gain approval of generic Zometa and the GMP non-compliance was observed in the second facility.
With "the location being the same, the entire products of the facility are under alert," he told stakeholders in a conference call discussing the import alert in May .
Trouble Both Sides of the Pond
The news comes just ten days after the UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), ordered Wockhardt to recall 16 drugs manufactured at the plant, due to GMP violations, discovered in an inspection carried out at the same time as the FDA.
According to the agency, these included the risk of cross-contamination due to “poor cleaning practices and defects in building fabric and the ventilation systems at the site.”
The MHRA also suspended manufacturing at Waluj with a certificate of non-compliance with GMP just days beforehand.
“We obviously liaise closely with the FDA and we are aware of their warning letter,” MHRA spokesperson Peter Donelan told in-Pharmatechnologist.com. “We are not planning to take any further action for this site as we have issued a statement of non-compliance and a medicines recall.”