The FDA issued a warning letter last year to PharMEDium Healthcare Holdings, the large compounding pharmacy operation that AmerisourceBergen ($ABC) said last week it would buy for $2.6 billion. But it turns out that FDA inspectors were back at the compounder's Cleveland center more recently and found that some problems with sanitation have yet to be resolved, while noting new issues.
The 9 observations are in a Form 483 the FDA only recently posted to its website. According to the document, FDA inspectors returned to the Cleveland facility in July. Among the problems that it found were 5 repeat violations for things like insufficient environmental monitoring of the aseptic processing area and the fact that employees who touched unsanitized equipment didn't change gowns or scrub up again before working on sterile meds.
Another repeat was the company's failure to do lab analysis to identify the strength of the active ingredient in drugs before they were sent to hospitals. "Without analytical results, the complaints you received about lack of effectiveness could not be fully investigated," inspectors told PharMEDium.
Inspectors also found that the lab was still not doing endotoxin testing or sterility testing on all products, even though some of those are "sterile injectable drug products including epidural and intrathecal injections and components labeled for IV use only."
Among new problems, the FDA said the facility was not doing enough to control for spore-producing organisms and since the first of the year had recorded 48 actions or alerts for a wide variety of species.
Pennsylvania-based AmerisourceBergen just last week announced its $2.575 billion deal to buy PharMEDium Healthcare from Clayton, Dubilier & Rice. The private equity group bought control of the compounding company in early 2014, in the midst of a watershed change in the industry when the FDA took on oversight responsibility for large operators like PharMEDium. Founded in 2003, PharMEDium has compounding centers in Tennessee, Mississippi, Texas and New Jersey, all registered with the FDA. It ships custom-made meds to more than 3,000 hospitals.
Last year's warning letter to PharMEDium was actually based on an inspection the FDA did in 2013 of all four of PharMEDium's centers where it noted a number of concerns about "insanitary conditions." The inspection was part of an FDA campaign to quickly inspect all of the largest compounders following a national outbreak of fungal meningitis that was tied to contaminated drugs sold by the now-defunct New England Compounding Center. The outbreak infected 751 people, killing 64 people who had received injections of a steroid for pain.
- here's the Form 483