# FDA 483 - Dynalabs LLC - September 26, 2019

Source: https://www.keypedia.com/records/483/dynalabs-llc/c42e6665-fe90-4922-8d79-4bb2c5e417a9

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

---

## Details

- Record Type: 483
- Company Name: Dynalabs LLC
- Inspection Date: 2019-09-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: DynaLabs LLC, a control testing laboratory in Saint Louis, MO, was cited for significant deficiencies in its quality control and laboratory operations. The inspection revealed that test methods for drug products lacked proper validation for customer-specific formulations, and the stability program was inadequate. Furthermore, deviations from procedures were not consistently recorded or justified, and the Quality Unit was found to be deficient in its responsibilities.

## 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/b0e4d9df-b27e-46a6-8fa6-0b2cc0582ee2)

## 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/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8