FDA 483 - Halocarbon Life Sciences, LLC - November 03, 2023

An FDA inspection of Halocarbon Life Sciences, LLC, a human and animal drug and API manufacturer located at 1100 Dittman Ct, North Augusta, SC, was conducted from October 30, 2023, to November 3, 2023. The inspection identified one observation related to the firm's quality system.

The firm failed to submit 15-Day NADA/ANADA alert reports for serious and unexpected adverse drug events within 15 working days of receiving the information, as required. Specific instances include: * **Complaint 19-012 (Lot 1118015, Isoflurane):** Received April 19, 2019, regarding respiratory distress and one patient death. Reported September 11, 2019 (145 days late), and only after an August 2019 inspection. * **Complaint 19-0021 (Lot J119007, Isoflurane):** Received December 5, 2019, regarding red hives, heart rate issues, and large lymph nodes. Not reported to FDA as of November 3, 2023 (1429 days late). * **Complaint 20-001 (Lot K317076, Sevoflurane):**