Indian Manufacturer Of Generic Drugs Faces Serious Quality Control Questions After FDA Inspection

About 200 miles east of Mumbai, a factory is responsible for producing a generic version of one of the most popular heart medications sold in the US. The India plant owned by Wockhardt Ltd is responsible for supplying a generic substitute for Toprol-XL commonly prescribed to cardiology patients in the US. Wockhardt faces serious accusations regarding their alarming quality control practices after Food and Drug Administration (FDA) inspectors visited the plant in July of 2013.

Wockhardt’s shares are sliding after FDA findings brought 16 “observations” against the India plant that produces their best-selling product. This serious “vote of no confidence” from the FDA includes reports of mold growing in storage-areas which house raw materials and open drains spilling over with urine. Wockhardt’s dilapidated factory in Chikalthana, India produces metoprolol, which is the popular medication marketed as Toprol-XL by AstraZeneca PLC. Wockhardt’s product currently controls 26% of the market for metoprolol, giving the FDA report potentially far reaching implications in the industry.

The FDA filing in question is the second one this year that reports deviations from what the FDA calls current good manufacturing practices in the Chikalthana factory. Filed in July, the report includes observations such as urine smells coming from the open drains in men’s restrooms with inadequate piping, employee uniforms encrusted with filth, and moldy and unmaintained storage spaces housing finished drugs and raw materials alike.

Though the FDA has not found contaminated drugs, they have issued warning letters and mandated corrective action against the Wockhardt factory. Though the FDA maintains a policy not to comment on potential corrective action, there is a chance that Wockhardt could face curbed export activity. Wockhardt has released statements announcing newly hired consultants and a new quality supervisor following FDA corrective actions. While the Chikalthana factory is not alone in facing the scrutiny of the FDA mandate requiring inspection of all overseas drug producers, the 16 observations filed in the July report represent an infraction more severe than those of most cases.