Inspectors with the US Food and Drug Administration (FDA) have found microbial contamination, unevaluated adverse event reports, ongoing water leaks, contaminated hoods, multi-colored residues, insects and at least one bird in a compounding pharmacy owned by the same company now associated with a massive outbreak of fungal meningitis.
The observations-made in a FDA Form 483 inspection report of compounder Ameridose's Westborough, MA facility-closely track a 483 released on 28 October to the New England Compounding Center (NECC), whose products were found to have been contaminated with fungal meningitis.
That inspection found numerous instances of bacterial and fungal contamination, non-sterile autoclaves, vials visibly contaminated with "white, filamentous material" and air conditioning units routinely shut off at night.
The lapses at Ameridose appear to exceed those found at NECC. FDA's 20-page Form 483 details a cavalcade of violations indicating widespread failures of good manufacturing practices.
For instance, Ameridose's recording and reporting of adverse events frequently left out key communications from the official record and "contain[ed] vague, canned language to describe adverse events." FDA also said its observers found that Ameridose, "Failed to investigate microbial contamination observed at least 53 times during … sterility testing of sterile stock solutions intended to be used in the manufacture of sterile injectable drug products."
Added FDA: "It is noteworthy that when further testing was done, the testing often revealed additional non-sterile units."
A further litany of complaints was observed-a lack of potency testing, insufficient process validation, a lack of written procedures for key aspects of product testing-but the majority of FDA's deficiency observations were aimed at Ameridose's aseptic core.
Inspectors found:
- personnel using non-sterile clothing and with exposed skin
- a lack of environmental monitoring
- unmonitored aseptic hoods
- non-validated test methods
- unaddressed leaking water in the clean room
- cracked and corroded walls in a sterile manufacturing room
- "brownish structures" in the production hoods
- "thick residues of orange, brown and green" in at least seven hoods
- damaged hoods held together with plastic straps and containing broken glass
- "brownish discoloration" around the hoods
- large gaps around the doors leading to the sterile manufacturing room
- an "inadequate" processing clean room design
- insects in the building where sterile products were packaged and stored and within three feet of where products were manufactured
- a bird flying around the packaging and storage facility
- ignored alarms regarding changes in the pressure differential between adjacent clean rooms and uncontrolled areas
In a statement, Ameridose said: "Ameridose's history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product. Ameridose is committed to addressing all observations in order to enhance our existing systems."
The company has already initiated a voluntary recall for all products manufactured at the facility and its facility remains closed.