FDA issues Form 483 to compounder AmerisourceBergen is buying for $2.6B

The FDA issued a warning letter last year to PharMEDium Healthcare Holdings, the large compounding pharmacy operation that AmerisourceBergen 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.

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.

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.

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.

Source: Fierce