FDA 483 - North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding - March 10, 2022

From March 1 to March 10, 2022, the FDA inspected North American Custom Laboratories, LLC, dba FarmaKeio Superior Custom Compounding, located at 1736 N Greenville Ave, Richardson, TX 75081-1808. The facility produces sterile and non-sterile drug products. Robert A. Harris, Director of Business Development / Facility Manager, was the individual to whom the report was issued.

The inspection revealed eight observations:

1. **Non-pharmaceutical grade sterile water for injection (WFI) was used for sterilization and compounding.** Specifically, non-pharmaceutical grade WFI was used to sterilize Sermorelin Acetate 1mg/ml (Lot #34585) and to reconstitute CJC-1295 Acetate/Ipamorelin Acetate Injection (Lot #34383). Inadequate filter integrity tests were conducted, and drug products were distributed nationwide. 2. **Materials and supplies were not disinfected prior to entering aseptic processing areas.** A plastic tote containing sterile tubing, vials, and stoppers was not disinfected when placed in the ISO8 non-sterile compounding room or when introduced into the ISO5 buffer room or ISO5 LAFH. 3. **Non-sterilized equipment was used in sterile drug production.** Non-sterile scissors and a handheld crimper were wiped with sterile alcohol and used