Biochem Laboratories has found out just how thorough FDA inspectors can be. The contract testing lab's facility in Lyndhurst, NJ, has been cited by regulators for its assay procedures, test methods, poor cleaning methods, record keeping--right down to its questionable computer protocols uncovered during an inspection of the facility last year.
Data integrity is a big issue at the FDA, and Biochem's procedures left inspectors shaking their heads.
"All employees in your firm used the same username and password," the FDA noted in its Feb. 17 warning letter to Biochem. "In addition, you did not document the changes made to the software or data stored by the instrument systems. Without proper documentation, you have no assurance of the integrity of the data or the functionality of the software used to determine test results. Your firm had no system in place to ensure appropriate backup of electronic raw data and no standard procedure for naming and saving data for retrieval at a later date."
In its warning letter, the FDA notes that Biochem promised to update its protocols, but the agency wasn't satisfied.
"Your response, however, is inadequate because you do not describe how your firm intends to save and back-up the electronic raw data, nor whether your firm will implement audit trails on your computerized systems. Further, you do not provide a timeframe for accomplishing the intended corrective actions or describe the changes you have made to relevant SOP(s)."
Biochem wound up with a 15-day grace period to clean up its act once and for all. And the rest of the outsourcing lab industry can take a close look at what needs to be done to steer clear of a regulatory slap.
- here's the warning letter