# FDA 483 - Infinity Laboratories LLC - January 07, 2021

Source: https://www.keypedia.com/records/483/infinity-laboratories-llc/0b5ecafd-71a3-41fe-bbc2-f249f54ac4c7

> FDA 483 for Infinity Laboratories LLC on January 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infinity Laboratories LLC
- Inspection Date: 2021-01-07
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Infinity Laboratories LLC in Castle Rock, CO, a contract laboratory, received a Form 483 with four observations. The inspection revealed significant deficiencies in their quality system, including inadequate investigations into unexplained discrepancies and out-of-specification results. Additionally, issues were noted regarding incomplete laboratory records, lack of a data integrity program for electronic data, and insufficient controls for in-process materials and instrument calibration.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.keypedia.com/companies/infinity-laboratories-llc/bad45a66-b869-4687-926a-0a1ca82ac275

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