# FDA 483 - CHRI Laboratories, Inc. - June 14, 2022

Source: https://www.keypedia.com/records/483/chri-laboratories-inc/5b7d4aa9-89b1-46ff-a9a4-4cbe14fe9a90

> FDA 483 for CHRI Laboratories, Inc. on June 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CHRI Laboratories, Inc.
- Inspection Date: 2022-06-14
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: CHRI Laboratories, Inc. in Saint Paul, MN, a control testing laboratory, was cited for significant deficiencies in its quality control unit, testing method verification, instrument calibration, and personnel qualifications. The inspection revealed issues including inadequate training, a lapse in the QA Leader's contract, data integrity concerns with unvalidated systems, and a shortage of qualified staff for critical testing. These observations indicate a systemic breakdown in quality management and operational control.

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## Related Officers

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- [GDUFA Pharmaceutical Investigator](https://www.keypedia.com/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)

Company: https://www.keypedia.com/companies/chri-laboratories-inc/a16b4ec4-b9e0-424b-84b0-74cef5de1ed7

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d