FDA 483 - Integrated Health Concepts Inc. - July 23, 2021

During an inspection conducted from July 12-23, 2021, at Integrated Health Concepts Inc., a producer of sterile drugs located at 720 Aerovista Pl Ste D, San Luis Obispo, CA, the FDA observed two deficiencies. The inspection report was issued to Dylan A. Herr, Vice President of Quality and Compliance.

Observation 1 noted that personnel touched equipment or surfaces outside the ISO 5 aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves. Specifically, on July 14, 2021, an operator failed to sanitize gloves after touching equipment on the ISO 7 mixing room table before handling materials within the ISO 5 Biological Safety Cabinet (BSC) during the compounding of Albuterol/Ipratropium Bromide 2.5 mg/0.75 mg Solution for Nebulizer, Lot 071421-1.

Observation 2 identified that personnel blocked the movement of first pass air around an open unit. On July 14, 2021, an operator placed an IV bag containing drug product over the ISO 5 BSC air return vents, blocking downward airflow for approximately ten seconds following the compounding of the same Albuterol/Ipratropium Bromide solution. These observations indicate potential contamination risks in the sterile drug production process.