# FDA 483 - Ultra Chem Labs Corp - July 27, 2022

Source: https://www.globalkeysolutions.net/records/483/ultra-chem-labs-corp/ba061392-ce51-4f1a-8bf7-3a88139899b3

> FDA 483 for Ultra Chem Labs Corp on July 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ultra Chem Labs Corp
- Inspection Date: 2022-07-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Ultra Chem Labs Corp in Ontario, CA was inspected by the FDA, revealing significant deficiencies in its manufacturing processes for drug products, particularly Anti-Microbial Alcohol-Free Foaming Hand Sanitizer. The inspection found a complete lack of a quality control unit, inadequate testing of both raw materials and finished products, and an absence of a stability program and proper record-keeping. These issues indicate severe non-compliance with current good manufacturing practices.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)

Company: https://www.globalkeysolutions.net/companies/ultra-chem-labs-corp/90f42943-ba7c-42bc-b14e-5a1996a77e4c

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6