# FDA 483 - Caldic USA Inc - December 19, 2019

Source: https://www.keypedia.com/records/483/caldic-usa-inc/c5ac65e6-c2c4-43bf-a8ce-0bed05e845e9

> FDA 483 for Caldic USA Inc on December 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Caldic USA Inc
- Inspection Date: 2019-12-19
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Avatar Corporation in University Park, IL, an API manufacturer, from December 17-19, 2019, revealed one observation. The firm's Quality Unit failed to exercise strict controls over labeling issuance and reconciliation, leading to discrepancies in label counts for a production batch that went undetected during review and approval.

## Related Officers

- [Alan M. Roberts](https://www.keypedia.com/people/alan-m-roberts/b6565c30-6228-4f51-a1b7-369bffe54e9c)

Company: https://www.keypedia.com/companies/caldic-usa-inc/cbbbd121-ee69-4053-9814-03a38122dba0

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