# FDA 483 - Sterling Pharmaceutical Services LLC - February 18, 2022

Source: https://www.keypedia.com/records/483/sterling-pharmaceutical-services-llc/923798f7-0472-4daf-84cc-57871eadd827

> FDA 483 for Sterling Pharmaceutical Services LLC on February 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sterling Pharmaceutical Services LLC
- Inspection Date: 2022-02-18
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Sterling Pharmaceutical Services LLC, a sterile ophthalmic drug manufacturer in Dupo, IL, received a Form 483 with four observations. The inspection revealed significant deficiencies in aseptic processing validation, quality control unit procedures, investigation of discrepancies, and adherence to contamination prevention procedures. These issues indicate a systemic lack of control over sterile manufacturing processes.

## Related Documents

- [483 - 2018-04-06](https://www.keypedia.com/records/483/sterling-pharmaceutical-services-llc/4a03b7c7-301a-4073-8021-4aa75fe51b1d)
- [483 - 2021-05-14](https://www.keypedia.com/records/483/sterling-pharmaceutical-services-llc/f4c63542-45cf-4238-b833-a24062745c74)
- [WARNING_LETTER - 2022-02-18](https://www.keypedia.com/records/warning_letter/sterling-pharmaceutical-services-llc/00588ea5-24d4-4e1b-8f1f-03f548dd6e68)
- [483 - 2024-05-01](https://www.keypedia.com/records/483/sterling-pharmaceutical-services-llc/3bd2df63-7eb4-41b8-bea0-7f8ba72de3a7)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Michael Zubelewicz](https://www.keypedia.com/people/michael-zubelewicz/e6dd6fd5-988b-4c7d-bbfb-27a504ae5a03)

Company: https://www.keypedia.com/companies/sterling-pharmaceutical-services-llc/73705333-126e-43ca-a087-e2ca2717f15d

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