FDA Inspection 1168151 — Embryology Laboratory, LLC
The FDA completed an inspection of Embryology Laboratory, LLC on April 29, 2022 in Frontenac, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 29, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Frontenac, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |