# FDA 483 - Transom Symphony OPCO LLC - September 27, 2022

Source: https://www.keypedia.com/records/483/transom-symphony-opco-llc/107f406b-a579-40a3-86a0-1bb0cd2cbeb1

> FDA 483 for Transom Symphony OPCO LLC on September 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Transom Symphony OPCO LLC
- Inspection Date: 2022-09-27
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Transom Symphony OPCO LLC, a contract manufacturer in Rantoul, IL, received an FDA Form 483 citing significant deficiencies. The inspection revealed a lack of appropriate controls over computer systems, leading to potential data integrity issues. Additionally, the firm's quality control unit failed to adequately follow procedures for environmental monitoring, equipment calibration, and preventive maintenance of manufacturing lines.

## Related Officers

- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

Company: https://www.keypedia.com/companies/transom-symphony-opco-llc/6f3bea95-caaa-4cf7-8472-ce0a28ab05f1

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