FDA 483 - Park Avenue Compounding - September 28, 2021

This FDA Form 483 document details observations from an inspection of SSM Health Care St. Louis DBA SSM St. Clare Health Center, an outsourcing facility located at 1015 Bowles Ave, Fenton, MO, conducted from September 16-28, 2021. The report was issued to Melissa R. Mays, Director of Pharmacy.

**Key Observations:**

1. **Inadequate Investigation Records:** Written records of investigations into batch failures or component failures to meet specifications do not always include conclusions and follow-up. * **Specific Issue A:** Leaking IV bags of Potassium Chloride 40 mEq in 270 ml 0.9% Sodium Chloride for injection (lot b(4)) were observed on September 17, 2021, after passing 100% visual inspection. The firm identified approximately 100 leaking bags from the same 0.9% sodium chloride IV bag manufacturer lot (b)(4) since August 6, 2021. Units from lot b(4) of the Potassium Chloride product were distributed to hospitals despite identified leaks from the bag manufacturer lot. Other lots compounded with the same IV bag lot were quarantined. * **Specific Issue B:** Corrective and preventive actions (CAPA) for environmental monitoring (EM) and personnel monitoring (PM) failures by a sterile compounding technician were ineffective, with repeated occurrences of