FDA says Able Labs falsified drugs data

Able is on the brink of bankruptcy as their shares have lost almost half their value as a result of the FDA report Able Laboratories fabricated data.

The FDA report raised concerns about the quality control and reporting procedures within Able Laboratories and released twelve observations. The report goes so far as to say "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 FDA conducted this inspection of Able Laboratories between May 2 and July 1. During this inspection Able Laboratories suspended manufacturing and recalled all its products that were in distribution.

Able intends to seek a "consent decree of permanent injunction" in a letter of response to the FDA which would Able hope would allow them to keep operating under court supervision.