FDA Concern with Particle Contamination and Related Investigations Resurfaces in Warning Letter to Sterile Drug Contract Manufacturer

A mid-August warning letter addressing March inspection findings at contract drug manufacturer Hyaluron highlights FDA’s ongoing concerns with particulate contamination problems and their investigation in aseptic manufacturing.  The warning letter was issued to the CEO of New York-based Albany Molecular Research, Inc. (AMRI) which purchased ten-year-old Hyaluron in June after the inspection.

In the warning letter, the New England district explained that Hyaluron’s response to the 483 issued after the March 2 – April 1 inspection of the Burlington, Massachusetts facility did not contain “sufficient corrective actions” – in particular, concerning investigation of particulate contamination in finished products.

At Hyaluron, along with the particulate concerns, the agency cited a lack of:  ● procedures to prevent microbial contamination ● proper aseptic technique by employees ● documentation that items taken into the sterile core are sterile, and ● established valid in-process specifications.

[More on Hyaluron’s problems with particulates, related FDA findings at Genzyme and Hospira regarding particle contamination, and agency concerns with aseptic practices at Hyaluron as well as links to the relevant documents are provided for subscribers here.]