# FDA 483 - Microchem Laboratory - April 30, 2026

Source: https://www.keypedia.com/records/483/microchem-laboratory/6ce88365-397b-4a37-9f13-eee8ab2bda25

> FDA 483 for Microchem Laboratory on April 30, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microchem Laboratory
- Inspection Date: 2026-04-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Microchem Laboratory in Richardson, TX, from April 27-30, 2026, revealed significant deficiencies in the firm's quality management system and laboratory controls. The quality unit failed to adequately oversee qualification protocols and out-of-specification investigations, lacking proper documentation and scientific rationale. Additionally, laboratory controls were found to be deficient, with issues in method verification, validation, accuracy studies, and the absence of stability-indicating analytical methods.

## Related Officers

- [Milton J. De Jesus Tavarez](https://www.keypedia.com/people/milton-j-de-jesus-tavarez/24d4ed81-7c7e-42d2-8888-1c56c25eec67)
- [Jeffrey T. Prosterman](https://www.keypedia.com/people/jeffrey-t-prosterman/1343bea3-692d-484e-b29f-c9f8f052f09c)

Company: https://www.keypedia.com/companies/microchem-laboratory/be7a555e-778b-443a-a606-7467f5b67520

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab