FDA 483 - SCA Pharmaceuticals, LLC - November 19, 2019

The FDA Form 483 details significant failures in the firm's quality system and manufacturing processes.

**Violations and Observations:**

1. **Inadequate Investigation of Sterility Test Failures:** The firm failed to thoroughly investigate seven confirmed in-house sterility test failures of finished sterile drug products since October 2018 (batches 1218003930, 1219007440, 1219008117, 1219008966, 1219009160, 1219009289, & 1219012541). While all associated batches were rejected, investigations consistently attributed the root cause to "human error" without identifying the contaminating microorganism(s), despite using a fluorescence detection method.

2. **Personnel Exit Monitoring Exceedances:** From January to October 2019, there were approximately 105 instances where Personnel Exit Monitoring exceeded action limits for objectionable organisms, primarily from operator hoods (32 occurrences) and chests (50 occurrences). The firm did not identify a potential cause for this trend until an Environmental and Personnel Monitoring Trend Report was approved during the inspection (October 29, 2019). Recovered objectionable organisms included *Bacillus cereus*, *Staphylococcus aureus*, *Micro