# FDA 483 - Fresenius Kabi USA LLC - September 01, 2015

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/bf293339-7005-45af-931f-376032c0316d

> FDA 483 for Fresenius Kabi USA LLC on September 01, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA LLC
- Inspection Date: 2015-09-01
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Fresenius Kabi USA LLC in Melrose Park, IL, was inspected from August 17 to September 1, 2015. The inspection revealed a significant issue with the firm's packaging and labeling operations, specifically concerning the lack of independent verification for visual inspections of cut labels. This indicates a potential risk to product quality due to inadequate quality control procedures.

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## Related Officers

- [Compliance Officer at FDA](https://www.keypedia.com/people/christopher-d-leach/2a3c4b73-f082-4f33-aa2d-52d1abbb6d55)

Company: https://www.keypedia.com/companies/fresenius-kabi-usa-llc/f694c817-29ea-47cf-b819-8cf11fbfc4da

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