Hospira's ($HSP) FDA woes have moved to Australia. The agency scolded the U.S.-based company in a warning letter based on an injectables plant inspection in late February and early March, according to a Wednesday securities filing.
The good news is that the letter doesn't restrict production or exports, and Hospira doesn't expect it to affect its finances this year. But if the FDA ends up ratcheting up the pressure, that could affect Hospira's business.
The FDA cited Hospira for failing to properly investigate batch failures and product discrepancies, or failing to fully correct problems it found at the Mulgrave, Victoria, plant. The agency also wasn't happy with Hospira's initial response to the problems raised by FDA. The company also failed to set up an adequate system for monitoring aseptic processing areas, the letter says.
One inadequate follow-up, according to the FDA, was Hospira's failure to address crystal particles found in carboplatin injections. The company warned doctors in March to inspect vials of the chemotherapy drug to make sure they didn't contain particles--but that was months after the particles were first flagged, the agency says. Even now, the FDA says, Hospira hasn't fully corrected the problem, because crystals still routinely crop up in reserve samples.
Hospira has seen a series of recalls and warning letters, several because of particulate contamination found in its drug vials. Last month, the company pulled one lot of heparin injection after a customer reported finding a human hair in a vial. In May, Hospira recalled one lot of labetalol hydrochloride because of stainless steel particles found in a vial. Meanwhile, the FDA has zeroed in on some issues at a new plant Hospira is building in Vizag, India.
- read the SEC filing