FDA Inspection 1149487 — Embryology Laboratory, LLC
The FDA completed an inspection of Embryology Laboratory, LLC on Aug 18, 2021 in Frontenac, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 18, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Frontenac, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12225 | 21 CFR 1271.47(d) | Departures: recording and justifying |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12495 | 21 CFR 1271.85(d) | Retesting of semen donors |