# FDA 483 - Sterling Pharmaceutical Services LLC - May 14, 2021

Source: https://www.keypedia.com/records/483/sterling-pharmaceutical-services-llc/f4c63542-45cf-4238-b833-a24062745c74

> FDA 483 for Sterling Pharmaceutical Services LLC on May 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sterling Pharmaceutical Services LLC
- Inspection Date: 2021-05-14
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Sterling Pharmaceutical Services, LLC, a sterile ophthalmic drug manufacturer in Dupo, IL, was cited for significant deficiencies across its aseptic processing, environmental monitoring, investigation practices, and quality control unit. The inspection revealed issues with preventing microbiological contamination, inadequate environmental controls, and insufficient investigations into critical deviations and out-of-specification results. These findings indicate a systemic breakdown in maintaining a state of control for sterile drug manufacturing.

## Related Documents

- [483 - 2018-04-06](https://www.keypedia.com/records/483/sterling-pharmaceutical-services-llc/4a03b7c7-301a-4073-8021-4aa75fe51b1d)
- [483 - 2022-02-18](https://www.keypedia.com/records/483/sterling-pharmaceutical-services-llc/923798f7-0472-4daf-84cc-57871eadd827)
- [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

- [Gretchen L. Trendel](https://www.keypedia.com/people/gretchen-l-trendel/4de8009a-85c5-4a1c-a6c8-53b110b19bee)
- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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