# FDA 483 - Purechempros LLC - November 22, 2022

Source: https://www.keypedia.com/records/483/purechempros-llc/cdfc66d5-1b51-45a3-a11b-0709c6b5da39

> FDA 483 for Purechempros LLC on November 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Purechempros LLC
- Inspection Date: 2022-11-22
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Purechempros LLC, a non-sterile drug manufacturer in Tempe, AZ, was inspected by the FDA from November 17-22, 2022, revealing significant deficiencies across its quality, laboratory, production, and facilities systems. The firm lacks fundamental controls for manufacturing Liquid Hand Sanitizer and Food Grade Hydrogen Peroxide, including the absence of a quality control unit and inadequate laboratory testing. Key issues also include unvalidated processes, insufficient stability testing, and poor equipment maintenance and cleaning records.

## Related Documents

- [WARNING_LETTER - 2022-11-22](https://www.keypedia.com/records/warning_letter/purechempros-llc/a6dd5078-7241-44f4-b852-a491d5d6f52c)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/purechempros-llc/caa2b1f2-639f-4e89-acff-b4896f2420b7

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face