The agency inspected Alaunus Pharmaceuticals, which is located near the NECC, three times over the past month and discovered that tests were not performed to assure containers used to hold individual active pharmaceutical ingredients are not reactive, additive or absorptive. In addition, master and batch documentation, as well as stability testing, were deficient.
The problems were noted in a so-called 483 inspection report released by the FDA, which has been scrambling to get a handle on the problems at the NECC and another compounding pharmacy owned by Conigliario and Cadden. The 483 report lists Conigliaro as the general manager and the street address indicates Alaunus is on the same block as the NECC in Framingham, Massachusetts (see here).
The report says that Alaunus repackages Fentanyl, Morphine Sulfate, Methadone, Hydromorphone, and Bupivicaine bulk API, although the company web site says Alaunus is focused on developing, producing, marketing and distributing "a wide range of generic pharmaceutical products." The site also says Alaunus will expand its product portfolio by "numerous Abbreviated New Drug Application products in various stages of development" (look here).
The report is the latest difficulty facing Conigliaro and his partner, Barry Cadden, who have suspended operations and recalled products from both compounding pharmacies amid investigations by Congress, the FDA and Massachusetts state health officials. Since the outbreak surfaced last month, 490 cases of meningitis have been reported, including 34 deaths (look here).
The outbreak is one of the worst public health crises in decades and has cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercised their authority. The FDA has repeatedly maintained that state health officials generally have responsibility for compounders, except when they initiate the equivalent of mass production.
Unlike traditional compounders that make specific medicines prescribed for individual patients, the NECC has produced large quantities of medicines and shipped them to hospitals and clinics in various states. And since the FDA issued a warning letter to the NECC in 2006 for various infractions, Congress has criticized the agency for failing to pursue enforcement action.
In testimony before Congress last week, FDA commish Margaret Hamburg insisted that court rulings have limited agency authority and so she proposed creating a two categories of compounding pharmacies - traditional and non-traditional - so that higher-risk production can be more closely regulated (read this).
At one of two hearings last week, Cadden, who is Conigliaro's partner in all three companies, invoked his right not to testify under the Fifth Amendment (see here). Meanwhile, Conigliaro and Cadden likely face criminal charges, according to (The Boston Globe. And the Senate Health, Education, Labor and Pensions Committee earlier this week sent letters to all 50 state boards of pharmacy to learn about their oversight of compounders.
In other inspections conducted by the FDA, the agency found 'greenish-black foreign matter' at the NECC and an air conditioning system that was turned off at night in an area used to store, package and produce medicines. This is an issue because room temperature is supposed to remain constant (back story).
And at Ameridose, FDA inspectors found cracked and corroded walls where products are prepared; rodents were in the building; insects were found in sterile areas where products are packaged and stored; a bird flying around in the same area; final drug products were not tested for potency; and 53 instances of microbiological contamination and three sterility failures were not investigated, according to the FDA (back story).