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

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