FDA Inspection 1280796 — North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
The FDA completed an inspection of North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding on September 5, 2025 in Richardson, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 5, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Richardson, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22749 | FDCA 501(a)(2)(A) | Production areas, difficult to clean/particle generating |