FDA 483 - Park Avenue Compounding - November 16, 2017

This FDA Form 483 was issued to Kristina N. Bryowsky, Director of Pharmacy at SSM Health Care St. Louis dba SSM St. Clare Health Center, an Outsourcing Facility located at 1015 Bowles Avenue, Fenton, MO 63026. The inspection occurred from October 23, 2017, to November 16, 2017.

Six observations were noted:

1. **Inadequate Investigation Scope:** Investigations into unexplained discrepancies, such as a media fill failure on July 28, 2017, did not extend to all relevant sterile drug product batches. For example, Norepinephrine batches produced before July 12, 2017, were not assessed, despite being made via the same process. 2. **Unsanitary Facility Maintenance:** On October 24, 2017, reddish-orange discoloration was observed throughout ISO 5 LAFHs, and a gray substance was found behind a HEPA filter frame during Phenylephrine HCl production. 3. **Deficient Environmental Monitoring:** The aseptic processing area's monitoring program for the ISO 5 hood lacked daily active viable air monitoring, daily surface monitoring of work surfaces, routine monitoring of personnel gowns, and established alert/action limits for personnel gloved fingertips and settling plates. 4. **Unsupported Expiration Dates:** Eight lots of Nicardipine