# FDA 483 - Fareva Morton Grove - August 12, 2025

Source: https://www.globalkeysolutions.net/records/483/fareva-morton-grove/651c2679-0589-410c-aa21-4581311b0ac1

> FDA 483 for Fareva Morton Grove on August 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fareva Morton Grove
- Inspection Date: 2025-08-12
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Fareva Morton Grove revealed critical deficiencies in their manufacturing processes, particularly concerning the water system design and microbial control. The firm failed to adequately identify gram-negative rod organisms in water samples and did not test drug products for objectionable microorganisms like Burkholderia cepacia. Additionally, significant issues were noted in record-keeping for equipment cleaning, laboratory data, and the stability program, indicating a lack of robust quality control and potential risks to product safety and integrity.

## Related Documents

- [WARNING_LETTER - 2025-08-12](https://www.globalkeysolutions.net/records/warning_letter/fareva-morton-grove/340f3953-dde1-4252-abd2-75bd0c70030c)

## Related Officers

- [Anna M. Spiros](https://www.globalkeysolutions.net/people/anna-m-spiros/13e6a69c-d3d5-431c-9895-0df9b86691b7)
- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.globalkeysolutions.net/companies/fareva-morton-grove/baf4391f-2077-4c00-8277-7fab233b2088

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669