# FDA 483 - Reliant Compounded Solutions Monroe, LLC - July 27, 2021

Source: https://www.globalkeysolutions.net/records/483/reliant-compounded-solutions-monroe-llc/809bcd5f-1783-4c03-8533-12200fa05d78

> FDA 483 for Reliant Compounded Solutions Monroe, LLC on July 27, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliant Compounded Solutions Monroe, LLC
- Inspection Date: 2021-07-27
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Compounded Solutions in Pharmacy, LLC in Monroe, CT was inspected and cited for multiple deficiencies related to aseptic processing, environmental controls, and product integrity. Observations included improper disinfection of materials, inadequate gowning procedures, insufficient sporicidal agent use, and compromised storage conditions for drug products. These issues indicate a significant risk to the sterility and quality of both sterile and non-sterile compounded drugs.

## Related Documents

- [483 - 2017-03-03](https://www.globalkeysolutions.net/records/483/reliant-compounded-solutions-monroe-llc/98a6164c-b691-41a9-b68d-33531be6378b)
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## Related Officers

- [Johnna L. Bleem](https://www.globalkeysolutions.net/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)
- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.globalkeysolutions.net/companies/reliant-compounded-solutions-monroe-llc/8b9b45b5-124f-485c-9500-5c84f425c9e6

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7