(Reuters) — Hospira (NYSE:HSP), which agreed in February to be bought by Pfizer (NYSE:PFE), said the FDA sent it another warning letter detailing violations in standard drug manufacturing practices at 1 of its facilities.
The FDA said its inspectors had visited the company’s plant in Liscate, Italy, twice in May last year and identified significant violations, including a failure to establish procedures to prevent contamination and to thoroughly investigate instances where a batch did not meet specifications.
Hospira’s response to the FDA’s concerns lacked "sufficient corrective actions," the agency said.
The letter, dated March 31, does not restrict the production or shipment of pharmaceutical products from the facility, Hospira said today.
However, the FDA warned in its letter that it could withhold approval of new applications or supplements made by Hospira until it confirmed that the facility was FDA-compliant.
The company, which makes biosimilars and generic versions of injectable drugs as well as pumps used to deliver them, has received warning letters for multiple facilities and has also issued a slew of drug recalls in the past year.
The company’s stock was down marginally at $87.70 in mid-afternoon trading today.