The report gives twelve observations that raise concerns about the quality control and reporting procedures within Able. Most pertinently the report claims “the quality unit and senior management failed to assure all drug products distributed have the safety, identity, quality, and purity that they are represented to possess”.
The inspection of Able’s processes took place between May 2 and July 1 this year, during which time Able suspended manufacturing and recalled all its products in distribution.
In a letter of response to the FDA report, Able expressed its intention to seek a “consent decree of permanent injunction”, which would allow Able to keep operating under court supervision.