Cook Pharmica, a biologics manufacturing company Catalent bought last year, was hit with a Form 483 by the FDA following an inspection that uncovered problems with a high number of mold recoveries at the site along with quality control and records issues.
The CDMO biologics plant, which Catalent bought last September for $950 million as part of an overall corporate expansion plan, was inspected by the regulatory agency in late April and early May. The FDA recently posted the citation to its website.
According to the FDA, inspectors found “an unacceptably high number of mold recoveries in the classified rooms used for the manufacture” of bulk drugs. The agency said the number of mold recoveries has been “trending” higher since 2015.
Additionally, the agency said there were problems with the plant’s written procedures to prevent contamination as well as quality oversight issues. In all, Cook Pharmica was cited with five observations.
In an email today, Catalent said that the company had "self-identified" most of the items in the observations and a corrective and preventive action plan (CAPA) was in place before the pre-approval inspection.
"Catalent remains confident in the robustness of the quality systems and inspection history at our Bloomington, Indiana site, as evidenced by a more recent FDA inspection with zero observations." the company said.
The 875,000-square-foot Cook facility, which was founded in 2004, has capabilities in sterile formulation and fill/finish across liquid and lyophilized vials, prefilled syringes.
Catalent snapped up the company last year amid a flurry of industrywide M&A activity that saw Thermo Fisher Scientific complete a $7.2 billion acquisition of CDMO Patheon. That came on the heels of Lonza’s $5.5 billion buyout of capsule maker Capsugel.