# FDA 483 - AltaThera Pharmaceuticals LLC - September 19, 2019

Source: https://www.globalkeysolutions.net/records/483/altathera-pharmaceuticals-llc/7482ae77-425a-438e-acb8-aba3676d7a33

> FDA 483 for AltaThera Pharmaceuticals LLC on September 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AltaThera Pharmaceuticals LLC
- Inspection Date: 2019-09-19
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Alt-Thera Pharmaceuticals, LLC in Chicago, IL, was inspected from September 17-19, 2019, and received one observation. The firm's quality control unit was cited for lacking responsibility over contract manufactured drug products. This included failures to investigate deviations and perform timely quality audits of their contract manufacturing organization.

## Related Documents

- [EIR - 2022-06-17](https://www.globalkeysolutions.net/records/eir/altathera-pharmaceuticals-llc/ec8457ab-e8a2-4fe6-9075-4430391e5d3e)
- [483 - 2022-06-17](https://www.globalkeysolutions.net/records/483/altathera-pharmaceuticals-llc/61cf4a9f-8db8-48d3-b91e-6ca77e7d203d)

## Related Officers

- [Alan M. Roberts](https://www.globalkeysolutions.net/people/alan-m-roberts/b6565c30-6228-4f51-a1b7-369bffe54e9c)
- [Peng Zhou](https://www.globalkeysolutions.net/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

Company: https://www.globalkeysolutions.net/companies/altathera-pharmaceuticals-llc/d1d8d591-195a-47d1-a65b-38e3298a6841

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