FDA 483 - Tri-Coast Pharmacy - October 21, 2016

This FDA Form 483 report details observations from an inspection of Tri-Coast Pharmacy, Inc., a producer of sterile drug products located at 14125 U.S. Hwy 1, Juno Beach, FL 33408. The inspection was conducted from October 11-14, 17, and 21, 2016. Kevin P. O'Connell is identified as the owner.

The inspection revealed nine observations:

1. **Actionable microbial contamination:** High levels of gram-negative rods, coagulase positive staphylococcus, molds, and yeast were detected in the ISO 5 area and adjacent areas during routine environmental monitoring on July 7, 2016. Specific locations showed significant CFU counts, including Acinetobacter radioresistens. The firm continued sterile drug production without evaluating the impact of this growth, and two lots (L-Carnitine 250mg/ml inj. lot #09082016A and Glutamine/Arginine/Carnitine 25/100/200mg/ml inj. Lot #091520160) failed sterility testing in September 2016. Surface sampling frequency was also deemed inadequate.

2. **Lack of sterilization validation:** The firm failed to conduct sterilization validation for a specific piece of equipment used since December 2