# FDA 483 - Accuon Labs, Inc - August 31, 2023

Source: https://www.keypedia.com/records/483/accuon-labs-inc/f83a7cc3-ab9e-40f6-970f-f1e86dab9956

> FDA 483 for Accuon Labs, Inc on August 31, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accuon Labs, Inc
- Inspection Date: 2023-08-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Accuon Labs, Inc. in Hauppauge, NY, was inspected from August 25-31, 2023, and received a Form 483. The inspection revealed significant deficiencies in laboratory controls, specifically concerning the construction, qualification, and environmental monitoring of clean rooms intended for microbial testing. These issues indicate a risk of contamination or mix-ups due to inadequate facility controls.

## Related Officers

- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/accuon-labs-inc/05b05575-7dfc-4ed4-b00a-d21260d0438d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961