# FDA 483 - Dynalabs LLC - September 26, 2019

Source: https://www.keypedia.com/records/483/dynalabs-llc/b0e4d9df-b27e-46a6-8fa6-0b2cc0582ee2

> FDA 483 for Dynalabs LLC on September 26, 2019. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dynalabs LLC
- Inspection Date: 2019-09-26
- Office Name: Kansas City District Office
- Summary: 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

## Related Documents

- [483 - 2012-10-29](https://www.keypedia.com/records/483/dynalabs-llc/58279535-db6a-49e3-9a5b-9a3909f2a97c)
- [483 - 2019-09-26](https://www.keypedia.com/records/483/dynalabs-llc/c42e6665-fe90-4922-8d79-4bb2c5e417a9)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-g-truchan/02e7c6e8-7bad-4a84-a0b7-ecd4f01e659e)
- [Nicole A. Lloyd](https://www.keypedia.com/people/nicole-a-lloyd/a9163483-4671-4d79-b173-3daae1eb4e31)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

Company: https://www.keypedia.com/companies/dynalabs-llc/587bc1ff-dada-4c06-8730-e936ed98ab03

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79