# FDA 483 - Compounded Solutions in Pharmacy, LLC - July 27, 2021

Source: https://www.keypedia.com/records/483/compounded-solutions-in-pharmacy-llc/e5246095-bd12-4513-aa81-9d6fd8d80412

> FDA 483 for Compounded Solutions in Pharmacy, LLC on July 27, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Compounded Solutions in Pharmacy, LLC
- Inspection Date: 2021-07-27
- Product Type: Drugs
- Office Name: New England District Office
- Summary: The FDA Form 483 inspection identified several deficiencies in the facility's sterile and non-sterile compounding operations.

**Sterile Compounding Issues:**

*   **Inadequate Disinfection:** On July 22, 2021, a cleanroom operator failed to disinfect individually packaged supplies and drug vials (e.g., Timolol/Brimonidine, Testosterone, Triple P Injectable) before introducing them into the ISO 5 area.
*   **Improper Gowning:** On July 22, 2021, a cleanroom operator allowed gown sleeves to touch the ISO 7 buffer room floor during donning, then used the same gown for aseptic filling in the ISO 5 hood.
*   **Inadequate Sporicidal Use:** SOP #3.020 allows cleaning without sporicidal agents in the ISO 8 Anteroom, indicating insufficient sporicidal use in cleanrooms and ISO 5 areas.
*   **Pressure Differential Excursions:** From November 2, 2020, to December 16, 2020, and February 16-17, 2021, the Non-Hazardous Sterile Compounding Room and Anteroom had inadequate differential pressure readings, violating SOP #3.010. No investigation was initiated for products produced during these excursions (e.g., Triple P Injectable, Doxycycline Ophth

## Related Documents

- [WARNING_LETTER - 2017-03-03](https://www.keypedia.com/records/warning_letter/compounded-solutions-in-pharmacy-llc/c24867f8-adc2-4ba8-a21b-d24b2b3f1bf9)

## Related Officers

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

Company: https://www.keypedia.com/companies/compounded-solutions-in-pharmacy-llc/d9901142-b344-40e9-b348-55f65fd3bfae

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144