Drug distributor AmerisourceBergen ($ABC) has pledged to set the bar high on quality at Pharmedium Healthcare Holdings, the compounding pharmacy company for which it laid out $2.6 billion. The challenges, however, keep mounting as FDA inspections continue to note issues at its manufacturing facilities.
The FDA posted another Form 483 for a Pharmedium compounding facility last week, this one at the company's headquarters in Lake Forest, IL. It followed an inspection in November that turned up half a dozen observations. In the past year, the FDA has issued Form 483 observations at Pharmedium facilities in Texas, Mississippi, New Jersey and Tennessee, as well as at its Illinois headquarters.
FDA inspectors noted, among other issues, that the Chicago-area facility had released 16 lots of products that were out of spec for potency and purity. They also noted that results from stability testing were not used in determining expiration dates. In addition, they said that when the facility received a complaint about a product, it did not investigate whether the same issue might have affected other batches.
AmerisourceBergen declined to comment.
During an earnings call last fall, CEO Steven Collis acknowledged that due diligence conducted by AmerisourceBergen on Pharmedium ahead of the deal had been quick, but said the company would discuss with the FDA what needs to be done. "We expect that we will continue to set the bar for quality in this area," he assured investors.
Pharmedium is only one of dozens of compounders, large and small, where the FDA has noted deficiencies since taking more oversight over the industry a couple of years ago. In January, Berkeley, CA-based Abbott's Compounding Pharmacy began recalling all of its products after the FDA issued a Form 483 raising sterility concerns.
- here's the Form 483