New FDA Inspections’ Database — How Useful for FDA-Regulated Industry?

Jack Garvey |

The new Inspections Database (http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm) is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement actions and results across the country and rest of world. It is certain that the information will be of value to those parties that are interested in which companies have been taken to task by the FDA, and which states / geographies are being the most aggressively regulated by the Agency. Also, companies will relish identifying their main competitors within the data.

Deep analysis of the information may perhaps shed some additional light onto particular FDA approaches or focus areas. Unfortunately, though, it is doubtful that FDA-regulated industry has much to learn from the information in the database.   In short, the database provides almost no useful information regarding the identified deficiencies that led to the classification, either good or bad. There is just very little actionable information that an industry executive can learn from the data, with one significant exception. The database information should be a reminder to all regulated industry executives that the FDA is out there, inspecting your facilities and plants, and that it is not a matter of IF, but WHEN, the Agency will show up at your door. If this leads to a better understanding of how important it is to have solid systems and processes in place, then the database will have served a significant purpose.

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