USFDA warns Hospira over manufacturing violations

The health regulator cited microbiological contamination of drugs at its Chennai facility

The US Food and Drug Administration (USFDA) has issued a warning letter to US-based generic injectables manufacturer Hospira Inc for violations detected in following the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at its pharma facility in India.

Hospira, in its filing with the US Securities and Exchange Commission (SEC), said it had received a letter from the FDA on May 29, 2013, in relation to an inspection of the company’s pharma manufacturing facility being operated under the Indian subsidiary Hospira Healthcare India Pvt Ltd, at Irungattukottai in Chennai in October 2012.

The drug regulator in its statement said the firm failed to establish and follow appropriate written procedures that are essential in preventing microbiological contamination of drugs at its Indian facility.

FDA also noted it is concerned that similar violations were found during an inspection this year at the company’s US facility.

Speaking to Business Standard, Hospira Inc said: “We are in the process of reviewing details of the FDA letter. However, we do not see any impact to the ongoing remediation efforts initiated at Chennai and other facilities.” He added the company saw no significant impact on its financial performance during the year.

In 2009, Hospira acquired the generic injectable finished dosage manufacturing facility of Orchid Chemicals and Pharmaceuticals Ltd for approximately $400 million.

Last year, it announced the acquisition of Orchid’s active pharmaceutical ingredient (API) manufacturing facility in Aurangabad, Maharashtra, together with an associated research and development (R&D) facility in Chennai for approximately $200 million.