# FDA 483 - Siegfried USA, LLC - September 27, 2023

Source: https://www.globalkeysolutions.net/records/483/siegfried-usa-llc/4817e4b9-75d4-49de-8126-941fc736a99e

> FDA 483 for Siegfried USA, LLC on September 27, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Siegfried USA, LLC
- Inspection Date: 2023-09-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Siegfried USA, LLC in Pennsville, NJ, an API manufacturer, received a Form 483 following an inspection from September 18-27, 2023. The inspection revealed that primary reference standards, resolution solutions, and reagents were stored outside of recommended temperature conditions since November 2022 without proper investigation. Additionally, the firm lacked written procedures for the quality oversight of laboratory refrigeration units, impacting the suitability and verification of test methods.

## Related Documents

- [EIR - 2023-09-27](https://www.globalkeysolutions.net/records/eir/siegfried-usa-llc/9583d279-5c95-422c-b41f-10e04ae0f31a)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.globalkeysolutions.net/companies/siegfried-usa-llc/0e21650d-f620-4e29-a62d-aa4ecd79cef2

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248