Able Laboratories
Able Laboratories was a generic drug company located in New Jersey. They had been inspected many times by the FDA.
When they were inspected by the FDA in 2005, they became one of the early examples of data integrity failures.
Some of the shortcomings described in the 15 page warning letter include but are not limited to the following:
- The firm submitted false data to the FDA in their submissions and did not adequately report and address Out of Specification events.
- They did not review their electronic laboratory data to identify failing results.
The firm quickly withdrew more than 50 ANDA filings and conducted drug recalls. They also volunteered to enter into a consent decree agreement with the courts. The FDA didn’t comply with this request and the firm filed for bankruptcy.
The key learning points from this scandal include:
- Submitting false data to the FDA is a criminal offense.
- All electronic data must be reviewed to identify and then investigate any failing results. One cannot simply report favorable results.
- The financial consequences of failing to comply with GMPs had catastrophic results to the company, and its employees even though no direct patient harm was identified.
- The FDA will take serious action even when failures in GMP compliance are not linked to adverse events suffered by the consumer.
