# FDA 483 - Hydrox Laboratories - June 24, 2021

Source: https://www.globalkeysolutions.net/records/483/hydrox-laboratories/aaa3fe6b-307d-44ab-8006-76e877d1fec3

> FDA 483 for Hydrox Laboratories on June 24, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hydrox Laboratories
- Inspection Date: 2021-06-24
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Hydrox Laboratories in Elgin, IL, was inspected by the FDA and received a Form 483 with nine observations indicating significant deficiencies in quality control and manufacturing practices. The inspection revealed failures in microbial testing, equipment cleaning and maintenance, adherence to written procedures, and the investigation of discrepancies and out-of-specification results. These issues suggest a systemic lack of control over critical aspects of drug product manufacturing, potentially impacting product safety and quality.

## Related Officers

- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
- [GDUFA Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)

Company: https://www.globalkeysolutions.net/companies/hydrox-laboratories/ee18c57b-aca4-4c13-80d3-92a4ecbf57d2

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669