Radnor, Pa.-based Airgas Inc.’s violations included the company’s failure to adequately expand an investigation of a contaminated nitrogen cylinder and filling batches of medical gas products without completing production records, according to the the watchdog agency’s letter.
The company’s responses to the problems were also insufficient, according to the FDA warning, which stemmed from July inspections of an Airgas facility in Chattanooga, Tenn.
The news comes amid a takeover fight between the company and competitor Air Products & Chemicals Inc. (NYSE:APD). The battle, which features a newly divided Airgas board, will likely be settled by a Delaware Chancery Court decision next year.
Steris, the Mentor, Ohio-based sterilization service company, came up short on its efforts to rectify a series of procedural failures that the FDA discovered at a Grand Prairie, Texas, plant, according to the agency’s warning letter.
Steris’ violations included various failures to establish adequate records and procedures to verify finished products’ conformity to sterilization specifications. The company’s errors resulted in differences between company and customer records; its corrective actions were also inadequate, according to the FDA.
Both companies were told to take “prompt action” to correct the problems listed in the warning letters or face possible seizures and/or injunctions without further notice. Steris was also warned of possible fines.