# FDA 483 - Sonoco TEQ Llc - June 10, 2022

Source: https://www.keypedia.com/records/483/sonoco-teq-llc/c792768c-73f7-4992-b1e0-60a0fdc89200

> FDA 483 for Sonoco TEQ Llc on June 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sonoco TEQ Llc
- Inspection Date: 2022-06-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Sonoco TEQ Llc in Fremont, IN, received a Form 483 with three observations concerning its manufacturing processes for Class II medical devices. The firm was cited for failing to establish procedures for monitoring and controlling validated process parameters, operating outside validated ranges, and using an inadequately validated manufacturing process without proper rationale for sterile barrier confirmation. Additionally, inspection equipment used for sterile barrier packaging was found to be uncalibrated for its intended use range.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/sonoco-teq-llc/5ca305ae-47c1-4441-ba76-17b62ea2582e

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0