FDA WARNING_LETTER - Accelerated Analytical Laboratories Inc. - May 12, 2017

The FDA inspected Accelerated Analytical Laboratories, Inc. from May 8-12, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The primary violation was the firm's failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

Specifically, the firm used unvalidated methods for: 1. Microbial recovery testing for objectionable organisms (e.g., *Burkholderia cepacia complex*) in oral rinse, failing to use stressed organisms in validation. 2. Bioburden analysis of water used in drug manufacturing, including for *Burkholderia cepacia complex*.

The firm's response, stating they would update reports to note unvalidated methodology if clients refused to sponsor revalidation, was deemed inadequate. The FDA emphasized that disclaimers do not negate CGMP requirements for validated methods, which are crucial for accurate drug release decisions. The firm also failed to outline plans to inform clients of these validation deficiencies.

As a contract testing lab, Accelerated Analytical Laboratories is considered an extension of the manufacturer and must operate in full CGMP compliance. The FDA requires a thorough retrospective investigation of all drug testing performed with unvalidated methods for drugs within expiry, and plans to inform clients, invalidate prior results, validate methods, or discontinue analysis until validation is complete. Failure to correct violations promptly may lead to legal