# FDA 483 - Liebel-Flarsheim Company LLC - April 08, 2025

Source: https://www.globalkeysolutions.net/records/483/liebel-flarsheim-company-llc/91593c21-3eff-43ab-af49-b2eaf6374da9

> FDA 483 for Liebel-Flarsheim Company LLC on April 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Liebel-Flarsheim Company LLC
- Inspection Date: 2025-04-08
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Liebel-Flarsheim Company LLC, a drug product manufacturer in Raleigh, NC, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into out-of-specification results, poor maintenance of aseptic processing areas and facility infrastructure, and the use of non-validated spreadsheets for critical laboratory testing. Additionally, employee training and adherence to aseptic sampling procedures were found to be insufficient.

## Related Documents

- [WARNING_LETTER - 2025-04-08](https://www.globalkeysolutions.net/records/warning_letter/liebel-flarsheim-company-llc/405244c0-775e-4179-820d-d13e0d032dca)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)
- [investigator](https://www.globalkeysolutions.net/people/daveta-l-bailey/b3c06872-638b-4c47-9539-a93b819be23f)

Company: https://www.globalkeysolutions.net/companies/liebel-flarsheim-company-llc/ca074473-a6a3-413d-828a-bee4671e7f97

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7