# FDA 483 - Sigma-Aldrich Mfg LLC - March 04, 2020

Source: https://www.globalkeysolutions.net/records/483/sigma-aldrich-mfg-llc/b1dd5143-4c47-4311-a86a-e18cb888796e

> FDA 483 for Sigma-Aldrich Mfg LLC on March 04, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sigma-Aldrich Mfg LLC
- Inspection Date: 2020-03-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Sigma-Aldrich Manufacturing LLC in Saint Louis, MO, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately validate a new filler and packaging line for a Class 3 medical device, lacked proper procedures for controlling nonconforming products, and did not document rework activities in device history records. Additionally, the inspection revealed that requirements for suppliers and contractors were not adequately established, with two suppliers not being on the approved list.

## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/sigma-aldrich-mfg-llc/b93ab22a-616b-4851-bcea-374f0888e88a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8