Hyaluron pulled up over particle contamination

US manufacturer Hyaluron has been sent a warning letter by the FDA after a routine inspection uncovered concerns with aseptic manufacturing at the company's plant in Burlington, Massachusetts.

The letter indicates the US regulator’s inspections in March and April of this year found a number of problems, including particulate contamination in finished products. That resulted in a Form 483 and, because the company's response detailing its corrective actions was not considered adequate, the FDA decided to issue an official warning letter.

Particle contamination has been at the heart of a number of FDA enforcement actions of late, including cases involving Johnson & Johnson, Genzyme, CSL Biotherapies and Hospira.

Among the issues uncovered by the FDA inspectors included contamination of both syringes and vials, as well as a failure by Hyaluron to carry out a formal risk assessment to determine any possible impact of the contamination of product quality.

The company also did not establish and follow "written procedures designed to prevent microbiological contamination of drug products purported to be sterile," said the letter, which can be viewed here.

The warning letter, dated August 17, was sent to Hyaluron's new owner Albany Molecular Research Inc (AMRI), a contract manufacturer which purchased Hyaluron back in June for $27 million as part of a plan to build its capacity in the filling and finishing of injectable biopharmaceuticals.

The manufacturing facility in Burlington was a key element of that purchase, particularly because of its ability to produce biologics in prefilled syringes, a market which is growing at around 10%-15% a year according to market forecaster Visiongain.

The FDA has given AMRI 15 days to respond to the warning letter and set out the steps it will take to correct the violations.

Phil Taylor