Some pharma folk see opportunity in the compounding industry for those operations that have the money to meet more stringent FDA standards and that can establish a national reputation for quality and service. One of those is QuVa, which jumped into the compounding business last year with backing from Bain Capital. But it is discovering the challenges of stepped-up FDA oversight of the industry, having recently been issued a Form 483 for one of its two Texas compounding locations it snapped up last year.
The citation is for the facility in Sugar Land, TX, that QuVa acquired in August from Helix, as part of its formation. FDA inspectors, who spent a more than a week in the facility, wrote it up for 5 observations, some of them for issues that predated QuVa's ownership.
Among the observations, the FDA said two sterility OOS investigations and 14 potency OOS investigations had been open for more than 30 days, indicating the lack of an efficient and robust corrective and preventive actions system. Inspectors said that the company had not determined what caused one lot of vancomycin to be OOS for endotoxin. The FDA noted that none of those lots were distributed.
Inspectors also noted that the facility's surface sampling in the aseptic processing area came up short, as did documentation of its cleaning and disinfecting of those areas.
In a statement, CEO and co-founder Stuart Hinchen said, "QuVa was pleased overall with the initial assessment of the FDA, and found the FDA observations relevant and consistent with QuVa's philosophy of continual improvement." He said responses have been provided to the FDA and that he believes QuVa's standards were evident in the acknowledgement in the amended 483 that only quality product was released to the public.
QuVa was formed in August by Hinchen and Chief Development Officer Peter Jenkins, with backing from Bain. Terms were not disclosed. The two founders came with experience in cGMP manufacturing from their previous positions as JHP Pharmaceuticals and Mayne Pharma. The company's focus is to produce sterile injectable drugs that hospitals are having trouble getting, generally because of manufacturing issues faced by traditional pharma companies. Both of its facilities are 503B registered, meaning that the company agrees they will meet FDA standards and volunteer to have them inspected by the agency.
Another early 503B registrant was Chicago-based Pharmedium, a large compounding operation that AmerisourceBergen acquired last year for $2.6 billion to extend the wholesaler's reach into U.S. hospitals. Pharmedium has also been tripped up in the FDA inspection process. 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. AmerisourceBergen has said it will get the issues resolved and that it intends to make quality a distinguishing feature for the compounder.
The tougher FDA oversight stems from a national outbreak of fungal meningitis in 2012 that was tied to contaminated drugs sold by the now-defunct New England Compounding Center. The outbreak infected 751 people who had gotten steroid injections, killing 64. The public outcry over the outbreak led Congress to pass the Drug Quality and Security Act, which gives the FDA new, but limited, powers to oversee compounding pharmacies that volunteer to be regulated. While the 503B program is voluntary, the FDA has said it believes those in the program will be viewed as having higher standards so that competition will weed out some of the bad players.
- read the Form 483