# FDA 483 - CHRI Laboratories, Inc. - May 03, 2023

Source: https://www.keypedia.com/records/483/chri-laboratories-inc/40fa9e41-bb1d-447e-88c6-1a566aa73417

> FDA 483 for CHRI Laboratories, Inc. on May 03, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CHRI Laboratories, Inc.
- Inspection Date: 2023-05-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: ChRi Laboratories, Inc. in St. Paul, MN, a contract laboratory, was cited for significant deficiencies during an FDA inspection. Observations included inadequate qualified personnel for drug product processing, unestablished accuracy and reproducibility of test methods, and a lack of scientifically sound rationale for microbiology laboratory cleaning procedures. One observation regarding personnel was a repeat from a previous inspection, indicating persistent issues.

## Related Documents

- [483 - 2022-06-14](https://www.keypedia.com/records/483/chri-laboratories-inc/5b7d4aa9-89b1-46ff-a9a4-4cbe14fe9a90)

## Related Officers

- [Norman K. Starks](https://www.keypedia.com/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766