FDA 483 - Dynalabs LLC - September 26, 2019

This FDA Form 483 details significant deficiencies at DYNALABS, a facility performing drug product testing, including for 503B customers.

**Key Violations and Observations:**

* **Test Method Validation Deficiencies:** The accuracy, specificity, and reproducibility of DYNALABS' "core" methods (DLMs) are not established for individual customer's unique finished dose drug formulations. DLMs are validated using USP-sourced active pharmaceutical ingredients (APIs) without incorporating customer-specific finished dose formulations, excipients, degradants, or impurities. This has led to approximately 114 laboratory event investigations (LEIs) for co-elution of peaks across at least 30 different API-specific DLMs since February 2019. Examples include Epinephrine and Omeprazole, where co-elution issues were unresolved, but passing potency/purity results were released to clients after customer approval for manipulation. * **Precision Issues:** The precision of "core" DLMs does not include intra-laboratory variation or repeatable results for customer-specific formulations, as intermediate precision studies also used USP-sourced APIs. * **Lack of Scientific Justification:** The firm could not provide scientific justification for excluding finished dose drug product formulations from method validation or evidence that "core" DLMs were equivalent or superior to available USP methods. * **Stability Program Deficiencies:** The written stability program lacks reliable, meaningful, and specific