# FDA 483 - Sigan America Llc - September 01, 2022

Source: https://www.globalkeysolutions.net/records/483/sigan-america-llc/6d1459e0-d40c-4e84-b5a5-1381871ca7c8

> FDA 483 for Sigan America Llc on September 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sigan America Llc
- Inspection Date: 2022-09-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: Sigan America LLC, a human drug manufacturer in Ottawa, IL, was cited for significant deficiencies in its quality control systems. Observations included a lack of established procedures for preventing objectionable microorganisms in non-sterile drug products, specifically regarding routine testing for B. cepacia. Additionally, the firm's equipment cleaning and maintenance procedures were found to be deficient, lacking adequate cleaning validation and root cause analysis for repeated microbial failures.

## Related Officers

- [Norman K. Starks](https://www.globalkeysolutions.net/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)

Company: https://www.globalkeysolutions.net/companies/sigan-america-llc/1438ee42-36af-495e-a79c-fe90cc947586

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766